Data / Medical devices / United States / Hill-Rom, Inc.
Hill-Rom, Inc.: FDA-registered device maker in Batesville, IN, United States, 8 510(k) clearances
Hill-Rom, Inc. is registered with the FDA (registration 1824206) in Batesville, IN, United States. It lists 30 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 13, 2026. 63 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1824206
- Address
- 1069 State Route 46 East, Batesville, IN, United States, 47006
- Owner or operator
- BAXTER HEALTHCARE CORPORATION (1417572)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 21, 1991
- Registered through
- 2026
- Brand names listed
- 3 position recliner, ADJUSTABLE, ALLEN DISPOSABLES SURG, ALLEN patient positioners, ATB - Modular Attachment for Mizuho OSI System, ATB Modular Attachment for Steris, Accumax, Advance Table [Allen] and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Traction | ILZ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Aid, Transfer | IKX | 1 | Specification developer | accessdata.fda.gov |
| Apparatus, Traction, Non-Powered | HST | 1 | Specification developer | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 | Specification developer | accessdata.fda.gov |
| Bariatric Bed | OSI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Bassinet, Hospital | NZG | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bed, Ac-Powered Adjustable Hospital | FNL | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bed, Air Fluidized | INX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bed, Flotation Therapy, Powered | IOQ | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bed, Manual | FNJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Chair And Table, Medical | KMN | 1 | Complaint file establishment | accessdata.fda.gov |
| Chair, Adjustable, Mechanical | INN | 1 | Complaint file establishment | accessdata.fda.gov |
| Component, Traction, Non-Invasive | KQZ | 1 | Specification developer | accessdata.fda.gov |
| Device, Transfer, Patient, Manual | FMR | 1 | Complaint file establishment, Contract manufacturer, Specification developer | accessdata.fda.gov |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | 2 | Manufacturer | accessdata.fda.gov |
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Specification developer | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Neurological Stereotaxic Instrument | HAW | 2 | Manufacturer | accessdata.fda.gov |
| Operating Room Accessories Table Tray | FWZ | 1 | Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Specification developer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Specification developer | accessdata.fda.gov |
| Stretcher, Wheeled | FPO | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stretcher, Wheeled, Powered | INK | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Network And Communication, Physiological Monitors | MSX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Table, Obstetric (And Accessories) | KNC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Table, Operating-Room, Electrical | GDC | 1 | Specification developer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 13, 2026 | K260211 | Dashboard (P007000) | MSX | Substantially Equivalent | Hill-Rom, Inc. | accessdata.fda.gov |
| November 18, 2022 | K223246 | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | BZQ | Substantially Equivalent | Baxter Healthcare Corproration | accessdata.fda.gov |
| March 4, 2021 | K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation | BZQ | Substantially Equivalent | Hill-Rom, Inc. | accessdata.fda.gov |
| June 26, 2020 | K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | PGW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| February 18, 2016 | K153247 | Fusion Compact Navigation System | PGW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| March 10, 2015 | K143414 | Hill-Rom Wireless Connectivity Module | IOQ | Substantially Equivalent | Hill-Rom | accessdata.fda.gov |
| June 3, 2013 | K122473 | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 | IOQ | Substantially Equivalent | Hill-Rom | accessdata.fda.gov |
| June 12, 2000 | K001284 | STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM | HAW | Substantially Equivalent | Medtronic Surgical Navigation Technologies | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 14, 2022 | 89562 | Class II | Terminated | (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices | Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail appropriately and could loosen over time causing the rail system to fall, potentially causing injury to caregivers and/or patients | accessdata.fda.gov |
| December 23, 2021 | 89414 | Class II | Ongoing | Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010 | Missing bushing on Liko M220 and M230 causing wear and potential for patient falling | accessdata.fda.gov |
| August 11, 2021 | 88548 | Class II | Ongoing | OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056 | Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from. | accessdata.fda.gov |
| May 28, 2021 | 88185 | Class II | Terminated | Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery mark | Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall. | accessdata.fda.gov |
| December 18, 2020 | 87053 | Class I | Terminated | Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabilitation. Affected devices: Liko Multirall 200 (product number 3130001) Universal Sl | Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, leading to the Multirall lift becoming detached from the rail system, potentially resulting in the fall of both the lift motor and the patient | accessdata.fda.gov |
| June 30, 2020 | 85925 | Class II | Terminated | Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medic | Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury. | accessdata.fda.gov |
| April 30, 2020 | 85610 | Class II | Terminated | Centrella Smart+ Bed, Catalog Number P7900 | The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit. | accessdata.fda.gov |
| January 12, 2018 | 79516 | Class II | Terminated | Progressa Bed - AC-powered adjustable hospital bed | A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and possible patient or user injury. | accessdata.fda.gov |
| February 23, 2017 | 76506 | Class II | Terminated | TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A). | The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that time period. | accessdata.fda.gov |
| August 9, 2016 | 75197 | Class II | Terminated | Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL. | Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if the Ceiling Bracket 71 with a larger center hole is used for a concrete ceiling Ultra System installation with the M8 screw and the safe working load is exceeded, the system could fall. | accessdata.fda.gov |
| July 15, 2016 | 74760 | Class II | Terminated | Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of | accessdata.fda.gov | |
| June 14, 2016 | 74615 | Class II | Terminated | Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in n | The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. To date there has been one report of a related injury. | accessdata.fda.gov |
| March 8, 2016 | 74107 | Class II | Terminated | Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Unive | The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. If the sling bar is not used as intended the bolt may be weakened. If the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. This hazard could cause potentially minor to catastrophic injuries to a patient. | accessdata.fda.gov |
| January 20, 2016 | 73138 | Class II | Terminated | Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric pati | The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury. | accessdata.fda.gov |
| October 7, 2015 | 72423 | Class II | Terminated | Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed | Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting. | accessdata.fda.gov |
| March 20, 2015 | 71132 | Class II | Terminated | Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift. | Complaints (including one reported death) allegedly of the lift arm drifting down suddenly. If the lift arm assembly is manually lifted, the actuator can become damaged and get stuck in the highest position. If a patient is lifted into the sling while the actuator is stuck, there is a potential risk of a free fall of the patient, resulting in minor or potent | accessdata.fda.gov |
| March 2, 2015 | 70675 | Class II | Terminated | Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece. | The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece. | accessdata.fda.gov |
| June 26, 2014 | 68650 | Class II | Terminated | Affinity Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting with | The attachment latch mechanism can become bent depending on user handling. Latch mechanism bending could lead to improper engagement of the foot section and this could result in injury to the user due to a fall. | accessdata.fda.gov |
| May 30, 2013 | 65259 | Class II | Terminated | TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used | When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. A patient attempting to get back into the bed may miss the seat and sit on the foot section instead. The patient can slide down to the floor, or | accessdata.fda.gov |
| April 30, 2013 | 64550 | Class II | Terminated | SlingBar 350. Designed to meet the needs for lifting humans. | Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom is requesting products be removed from field use and replaced with an updated design. | accessdata.fda.gov |
| April 15, 2013 | 65257 | Class II | Terminated | Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital. | Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame. | accessdata.fda.gov |
| February 26, 2013 | 64580 | Class II | Terminated | TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgi | In certain situations a software problem with the TotalCare SpO2RT 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. A correction to the software program is c | accessdata.fda.gov |
| December 6, 2012 | 62413 | Class II | Terminated | Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts. | Liko/Hill-Rom has received reports from facilities which indicate that serious injuries have been received related to the Standard Sling bar 450. There have been 6 complaints of injury related to the product over the past 32 years (6 out of 838,687,856 estimated patient uses). One of the injuries was associated with a patient during use, four injuries occurr | accessdata.fda.gov |
| October 31, 2012 | 62334 | Class II | Terminated | Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems Product Usage - The Overhead Rail System allows overhead lifts to be mounted to t | Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail system has failed to the extent that the overhead rails have fallen down while in use in high humidity (swimming pool) areas. Analysis of the incidents suggest that the components (hardware) used to secure the rail to the ceiling had corroded and may be unsuitable | accessdata.fda.gov |
| June 18, 2012 | 62331 | Class II | Terminated | Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital. | During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail. | accessdata.fda.gov |
| April 2, 2012 | 62453 | Class II | Terminated | Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Reco | During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of patient falling. Bed movement immediately prior to, or during the birthing process may still create distractions and delays, resulting in patient or caregiver falls, or contribute to a deviation in a | accessdata.fda.gov |
| February 3, 2012 | 60888 | Not yet classified | Terminated | Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized Therapy Unit provides a pressure-relieving sleep surface for patients in the home environment. It helps enable patients with pressu | The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed outer rail, which is extruded Aluminum tubing, is intended to be one piece joined together by a weld at | accessdata.fda.gov |
| February 21, 2011 | 57944 | Not yet classified | Terminated | TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The TotalCare Bed Systems is intended to provide a patient support ideally suited to be used in health care environments. The Total | Hill-Rom has become aware of a potential issue with some TotalCare and VersaCare beds equipped with the integrated P500 Microclimate Management (MCM) therapy surface, and with the VersaCare P500 MCM surface upgrade. Because of an unauthorized vendor part modification, it is possible that the MCM blower may not perform as originally designed. Given this modif | accessdata.fda.gov |
| February 9, 2011 | 57861 | Not yet classified | Terminated | Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko a Hill-Rom Company. Enables a comfortable sitting position and adapts to the patient without the need for individual adjustments wh | Slings were improperly assembled and the loops that are used to support the sling when hung from a lift were too long, potentially putting the patient being lifted at risk of falling out. | accessdata.fda.gov |
| February 3, 2011 | 57733 | Not yet classified | Terminated | Hill-Rom TotalCare Bed, P1900, Hill-Rom, Batesville, IN. TheTotalCare Bed System is intended to porvide patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a var | The firm received one report that a patient was weighed on the bed at 53 Kg when the patient actually weighed 73 Kg. The patient expired the next day and it is inconclusive as to whether the scale was a contributing factor. The firm investigated and found that the software for the scale system did not clear the last patient weight from the history of the sca | accessdata.fda.gov |
| January 27, 2011 | 57734 | Not yet classified | Terminated | Liko Sabina EE Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able | The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports, two were injuries in patints during use and four injuries were in non-patients when they tripped over the lift device and fell on the unit. | accessdata.fda.gov |
| June 11, 2010 | 56033 | Not yet classified | Terminated | Rolko Trapeze handles, part 148671, for use with Care Assist bed P1170 and Hill Rom 1000 bed P1160, Hill Rom Batesville, IN. Intended Use: The CareAssist and Hill-Rom 1000 Beds are intended for low to moderate acuity pat | The firm received a complaint regarding the plastic housing used to support the trapeze handle. The firm investigated and found that the manufacturer of the trapeze handle didn't correctly process the plastic component. Therefore the plastic had the potential to break prematurely. | accessdata.fda.gov |
| March 5, 2010 | 55301 | Not yet classified | Terminated | Excel Care Bariatric Bed, P 610A, Hill-Rom, Batesville, IN. Intended Use: The Excel Care Bariatric Bed is for bariatric patients with varying medical and physical conditions. The bed supports patients between 250 and 100 | The firm received complaints regarding the siderails not operating correctly or becoming inoperable. The siderails could experience false latching, unintentional lowering or become inoperable. There have been reports of 5 patient falls and 2 injuries to caregivers. | accessdata.fda.gov |
| January 1, 2010 | 54117 | Not yet classified | Terminated | Hill-Rom TotalCare Bed System, Hill-Rom, Batesville, IN; Model P1900 and P1840. The product is used as an AC powered adjustable hospital bed. | The controls for nurse call, bed movement and entertainment functions on the intermediate rail may fail to function. | accessdata.fda.gov |
| November 16, 2009 | 53987 | Not yet classified | Terminated | Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B. Intended to be used as birthing beds for momen of child bearing age in an labor, delivery, recovery or postpartum setting in | The brakes may not hold or lock. | accessdata.fda.gov |
| September 16, 2009 | 56018 | Not yet classified | Terminated | Hill-Rom 305 Bed, P1441B - Non electric, Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital. | The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the pivot pin E-ring, which could cause the E-ring to come off. | accessdata.fda.gov |
| April 20, 2009 | 51389 | Not yet classified | Terminated | Hill-Rom 100 Low Bed, Model P3930. AC-powered adjustable hospital bed. | The siderails may exhibit false latching, or unintentional lowering, or may become inoperable. | accessdata.fda.gov |
| April 13, 2009 | 55156 | Not yet classified | Terminated | Hill-Rom Care Assist Bed, Model P1170. | Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the side rail to the bed. | accessdata.fda.gov |
| March 9, 2009 | 51562 | Not yet classified | Terminated | Hill-Rom TotalCare Bed, Model P1900. The TotalCare (R) Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare (R) Bed System may be used in a variety of s | An e-ring may not have been installed during production, which could result in an inability to latch the siderail. | accessdata.fda.gov |
| November 24, 2008 | 50750 | Not yet classified | Terminated | Expressaire, Disposable Tourniquet Cuff 34", 1 line (18), sterile, Manufactured for Sammons Preston, A Patterson Medical Company, Cedarburg, WI.; Cuff type A70107010. Each cuff is marked ExpressAire by Sammons Preston an | The inflation tube may come loose at the connection to the cuff during use. | accessdata.fda.gov |
| November 11, 2008 | 50181 | Not yet classified | Terminated | Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed is a general purpose bed for use with low to medium acuity patients in the home care environment. | Failure, mechanical: If the bed mechanism is cranked downward when the bed is already in its lowest position, the springs may cause the bed to rise suddenly if the bed is empty, more slowly if occupied by a patient, or when the patient exits the bed. For further information, please contact Hill-Rom, Inc. at. | accessdata.fda.gov |
| April 28, 2008 | 47819 | Not yet classified | Terminated | Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers P9964-11, P9964-12, P9964-13, P-9964-14, P9964-15, P9964-16, P9964-41 and/or P9964-42. | A risk of entrapment will exist between the head and foot rails if installation instructions are followed. | accessdata.fda.gov |
| April 8, 2008 | 47469 | Not yet classified | Terminated | Hill-Rom 100 Low Bed; Model No. P3930. | The upper deck may collapse to its lowest position and the caster brakes may fracture if the bed is moved while the brakes are locked. | accessdata.fda.gov |
| April 3, 2008 | 46858 | Not yet classified | Terminated | Hill-Rom Procedural Stretcher with auto-contour option; Model P8000F. Wheeled hospital stretcher consisting of a platform mounted on a wheeled frame, designed to transport patients and to allow for patient care before, d | The auto contour function on/off handle may be inadvertently activated while the head of the stretcher is raised, increasing the possibility of the head section to become jammed and preventing it from lowering. This may result in a delay to the procedure. | accessdata.fda.gov |
| November 21, 2007 | 45807 | Not yet classified | Terminated | Hill-Rom Affinity Birthing Bed, Model P3600. | Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated. | accessdata.fda.gov |
| September 6, 2007 | 45444 | Not yet classified | Terminated | Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006 | Brake failure: The brakes may not hold or lock properly. | accessdata.fda.gov |
| November 12, 2006 | 38256 | Not yet classified | Terminated | Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN 47006 | False Latch/Failure to Latch-The side rail may not latch, or the latch may not fully engage, resulting in the siderail being able to be lowered without pulling on the release handle. | accessdata.fda.gov |
| August 18, 2006 | 36142 | Not yet classified | Terminated | Hill-Rom Affinity Three Birthing Bed, Model P3700. | The cable on the auxiliary outlet may become pinched, which may result in an electrical short with melting of the plastic transformer and the emission of smoke. | accessdata.fda.gov |
| July 27, 2006 | 36143 | Not yet classified | Terminated | Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200. | The patient pendant cord represents a potential trip hazard for the patient or the caregiver. | accessdata.fda.gov |
| May 20, 2005 | 32108 | Not yet classified | Terminated | Hill-Rom Century+ Bed, Model P1400. | Sleep bed pivot bolts may break, allowing the head section to shift or to drop to one side. | accessdata.fda.gov |
| March 1, 2005 | 31211 | Not yet classified | Terminated | Hill-Rom TotalCare SpO2RT pulmonary therapy bed system, Model 1900. | Siderails may stay up without latching into place. | accessdata.fda.gov |
| December 29, 2004 | 30783 | Not yet classified | Terminated | Hill-Rom brand VersaCare Bed; product P3200. | A potential trip hazard exists when the fracture frame adaptor bracket is installed on the bed without the fracture frame. | accessdata.fda.gov |
| November 29, 2004 | 30529 | Not yet classified | Terminated | Hill-Rom CareAssist Bed; model P1170. | Warning label containing instructions for proper electrical grounding was not attached. | accessdata.fda.gov |
| August 24, 2004 | 29897 | Not yet classified | Terminated | Hill-Rom brand VersaCare Bed; Model P3200. | Pivot bolts on the sleep deck may become loose and fall out, allowing the head section to shift or to drop to one side, and a grounding warning label is missing. | accessdata.fda.gov |
| June 28, 2004 | 29399 | Not yet classified | Terminated | Hill-Rom brand TotalCare Bed System; Model P1900. | An incorrect warning label was placed on these beds. Warning should say, "do not use for life sustaining equipment....." | accessdata.fda.gov |
| March 15, 2004 | 28465 | Not yet classified | Terminated | Hill-Rom brand TotalCare bed system; model P1900 -remanufactured only. | A warning label, advising users not to use oxygen tents with this equipment because of the potential for a fire, was not placed on these remanufactured beds. | accessdata.fda.gov |
| March 8, 2004 | 28420 | Not yet classified | Terminated | Hill Rom brand Advanta bed; model P1600. | A potential pinch/shear point exists between the restraint strap hook located underneath the knee section and the foot rail mounting of the bed. | accessdata.fda.gov |
| December 26, 2003 | 28009 | Not yet classified | Terminated | Hill-Rom brand Century+ bed; model P1400. | If fluid is spilled on the siderail or the bed control areas, the bed may change positions without user input. | accessdata.fda.gov |
| December 19, 2003 | 27950 | Not yet classified | Terminated | Hill-Rom Newborn bassinet; model P247. | The caster/wheel may come off of the bassinet, causing the bassinet to tip. | accessdata.fda.gov |
| November 14, 2003 | 27711 | Not yet classified | Terminated | Hill-Rom brand Resident LT bed ambulatory assist bar accessory; accessory P865A. | The ambulatory assist bar may not lock into position and may come out of place due to incorrect assembly. | accessdata.fda.gov |
| August 8, 2003 | 26933 | Not yet classified | Terminated | Integris Monitor Arm; model P997-04 | The monitor may separate from the monitor arm, allowing the monitor to fall from the arm. | accessdata.fda.gov |
| June 20, 2003 | 26586 | Not yet classified | Terminated | Hill-Rom Newborn bassinet; model P247 | The caster/wheel may come off of the bassinet, causing the bassinet to tip. | accessdata.fda.gov |
| April 24, 2003 | 25899 | Not yet classified | Terminated | Hill-Rom brand Affinity three birthing bed | Possible electrical shock hazard, as the power cord grounding pin may break off or become detached. | accessdata.fda.gov |
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Updated August 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.