Data / Medical devices / United States / Getinge Group Logistics America, LLC

Getinge Group Logistics America, LLC: FDA-registered device maker in E Windsor, NJ, United States, 1 510(k) clearance

Name: Getinge Group Logistics America, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Getinge Group Logistics America, LLC is registered with the FDA (registration 3012092534) in E Windsor, NJ, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 8, 2013. 13 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Getinge Group Logistics America, LLC

FDA registration number: 3012092534
FEI number: 3025504317
Address: 160 Princeton Highstown Road, E Windsor, NJ, United States, 08520
Owner or operator: Getinge (10055718)
Roles: Repackager or relabeler
First device listed: January 7, 2025
Registered through: 2026
Brand names listed: Maquet PowerLED

Devices it lists

Device	Product code	Class	Role	Source
Lamp, Surgical	FTD	2	Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Ceiling Mounted	FSY	2	Repackager or relabeler	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
May 8, 2013	K130513	VOLISTA 400; VOLISTA 600	FTD	Substantially Equivalent	Maquet S.A.S.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 11, 2021	87386	Class II	Ongoing	Operating Table System	There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning which may lead to the patient having to be transferred to another OR table causing a delay in the procedure.	accessdata.fda.gov
January 29, 2021	87301	Class II	Terminated	Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability	Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected and/or experienced System Check Out failures when docking the absorber to the Flow i Anesthesia machine.	accessdata.fda.gov
December 21, 2020	87155	Class II	Terminated	Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical instruments, containers, operating theatre shoes and operating theatre	The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. A broken hose connection may lead to a hazardous situation of water leakage or water spray. The water leakage or water spray may result in a burn to the user and/or an inconvenience due to a procedural delay if the W	accessdata.fda.gov
September 17, 2020	86548	Class II	Ongoing	Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It	A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.	accessdata.fda.gov
November 13, 2019	84352	Class II	Ongoing	Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000	Sterile barrier system may be compromised	accessdata.fda.gov
August 22, 2019	83664	Class II	Terminated	The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed	Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product wit	accessdata.fda.gov
July 22, 2019	83468	Class II	Terminated	Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.	Reversed expiration and manufacturing date on the label	accessdata.fda.gov
June 5, 2019	83233	Class II	Terminated	PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. I	The monitor displays an error message. The error message states "internal error restart or service".	accessdata.fda.gov
March 20, 2019	82533	Class III	Terminated	Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes.	Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes	accessdata.fda.gov
January 8, 2019	82074	Class II	Terminated	Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical ligh	The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.	accessdata.fda.gov
February 7, 2018	79583	Class II	Terminated	VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgi	The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.	accessdata.fda.gov
January 3, 2018	79536	Class II	Terminated	HEMASHIELD Knitted Double Velour Cardiovascular Fabric	A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).	accessdata.fda.gov
November 16, 2017	79340	Class II	Terminated	ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094	Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms at the weld seams that has the potential to develop into breaks with heavy use and aging of the equipment.	accessdata.fda.gov

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Updated May 8, 2013. 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.