Data / Medical devices / United States / MEDTRONIC NAVIGATION, INC. (Boxborough)

MEDTRONIC NAVIGATION, INC. (Boxborough): FDA-registered device maker in Boxborough, MA, United States, 6 510(k) clearances

Name: MEDTRONIC NAVIGATION, INC. (Boxborough) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

MEDTRONIC NAVIGATION, INC. (Boxborough) is registered with the FDA (registration 3004785967) in Boxborough, MA, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 21, 2024. 21 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3004785967
Address: 200 Beaver Brook Rd, Boxborough, MA, United States, 01719
Owner or operator: Medtronic, Inc. (2112641)
Roles: Remanufacturer, Specification developer
First device listed: March 7, 2006
Registered through: 2027
Brand names listed: O-Arm, O-Arm Imaging System, O-Arm O2 Imaging System, O-arm Equipment Drape, O-arm O2 imaging system, Surgical drape and drape accessories

Devices it lists

Device	Product code	Class	Role	Source
Drape, Surgical, Exempt	PUI	2	Specification developer	accessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Remanufacturer, Specification developer	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Remanufacturer, Specification developer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Remanufacturer, Specification developer	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
June 21, 2024	K240465	O-arm O2 Imaging System	OWB	Substantially Equivalent	Medtronic Navigation, Inc.	accessdata.fda.gov
April 24, 2020	K200074	O-arm O2 Imaging System	OWB	Substantially Equivalent	Medtronic, Inc.	accessdata.fda.gov
August 6, 2015	K151000	O-Arm O2 Imaging System	OWB	Substantially Equivalent	Medtronic, Inc.	accessdata.fda.gov
June 17, 2010	K092564	O-ARM IMAGING SYSTEM	OXO	Substantially Equivalent	Medtronic Navigation, Inc. (Littleton)	accessdata.fda.gov
March 29, 2006	K060344	O-ARM IMAGING SYSTEM	OXO	Substantially Equivalent	Breakaway Imaging, LLC	accessdata.fda.gov
May 5, 2005	K050996	O-ARM IMAGING SYSTEM	OXO	Substantially Equivalent	Breakaway Imaging, LLC	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
May 19, 2026	99041	Class II	Ongoing	Medtronic O-arm O2 Imaging System. Model Number: BI70002000.	Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.	accessdata.fda.gov
May 27, 2025	97045	Class II	Ongoing	O-arm O2 Imaging System. Mobile X-Ray System.	A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.	accessdata.fda.gov
April 26, 2024	94566	Class II	Ongoing	O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000	Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.	accessdata.fda.gov
July 25, 2023	92778	Class II	Ongoing	The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is in	Ground cable installed incorrectly.	accessdata.fda.gov
November 15, 2019	84441	Class II	Terminated	O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000	Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate wi	accessdata.fda.gov
May 1, 2019	82991	Class II	Terminated	Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS P	The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full recharge of the potential capacity and results in the inability of the system to take X-rays, open the gantry, and move the system from one place to another, which may affec	accessdata.fda.gov
September 17, 2018	81355	Class II	Terminated	Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R	O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit	accessdata.fda.gov
August 30, 2018	81153	Class II	Terminated	O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is inte	Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.	accessdata.fda.gov
January 25, 2018	79275	Class II	Terminated	O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number	Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power the system after shutdown, System stays in standalone mode, Image reconstruction, System/Pendant bootup, Dose display/report, Gantry motion, Network communication, System shutdown, and Early termination of 3D spin.	accessdata.fda.gov
September 30, 2017	79272	Class II	Terminated	O-arm O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting	During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that the high-power cable connector may come in contact with surrounding metal during the disconnecting/reconnecting process which may result in an electrical short and a shock to the field service technician.	accessdata.fda.gov
September 22, 2016	75279	Class II	Terminated	Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spi	O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images	accessdata.fda.gov
March 17, 2016	74158	Class II	Terminated	Medtronic Navigation O-arm 02 surgical x-ray imaging system	Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).	accessdata.fda.gov
March 17, 2016	74153	Class II	Terminated	Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028	It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.	accessdata.fda.gov
January 29, 2016	73303	Class II	Terminated	Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2	Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality	accessdata.fda.gov
July 25, 2013	67363	Class II	Terminated	Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a	Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h)	accessdata.fda.gov
January 31, 2013	64256	Class II	Terminated	Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile	Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction	accessdata.fda.gov
July 11, 2012	62571	Class II	Terminated	Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.	A fault in a high voltage relay in the 0-arm Imaging System might cause the relay to overheat and burn.	accessdata.fda.gov
October 15, 2010	57048	Not yet classified	Terminated	Medtronic Navigation O-Arm Imaging System, Door Assembly (BI-700-00006) used in Product Catalog Numbers: 9732719,9733346,81-700-00027, 81-700-00027R, 81700- 00027-100, 81-700-00027-1 OOR, 81-700-00027-120, 81-700-00027-1	Safety Notice: Door Cable Periodic Maintenance Schedule and Cable Wear for the O-ARM Imaging System Breakage of the door cable during opening and closing may occur and cause physical harm or delay of therapy	accessdata.fda.gov
October 12, 2010	61741	Class II	Terminated	Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.	Software Version 3.1.1 does not meet navigational accuracy.	accessdata.fda.gov
May 10, 2010	55675	Not yet classified	Terminated	O-Arm Imaging System The O-Arm imaging system is a mobile X-Ray system designed for medical applications in surgical theaters, focusing on 3D imaging but also offering 2D fluoroscopic Imaging.	The possibility that the real time image display can freeze up during use of a 2D continuous fluoroscopy.	accessdata.fda.gov
June 30, 2008	49501	Not yet classified	Terminated	BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for surgical applications.	Failure to of affected units to comply with EER/AKR limits due to misinterpretation of the measurement requirements specified in 21 CFR 1020.32 (d) (3) (iii)	accessdata.fda.gov

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Updated June 15, 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.