Littleton, MA, United States
Medtronic Navigation, Inc.-Littleton recalls
8 recalls recorded since 2018, most recently on 26 April 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)2
Terminated or completed6
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 April 2024
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, MN, PR, TX, WI and the countries of Bangladesh, Canada, Costa Rica, India, Mexico, Panama, Philippines.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2026-2024
- O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
Ongoing Class II Medical devices
- Recall started
- 25 July 2023
- Reason
- Ground cable installed incorrectly.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KY, MI, MO, NC, NV, OH, TN, UT, VA, & WA. The countries of Canada, Ireland, Poland, Russian Federation, Switzerland, & Viet Nam.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2449-2023
- 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
Terminated Class II Medical devices
- Recall started
- 15 November 2019
- Terminated
- 19 September 2023
- Reason
- 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 within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.
- Distribution
- US: AR CA CO CT FL ID IL IN KS KY MI MN MO NC ND NE NY OH OR PA SC SD TX VA WA WI WV OUS: AUSTRALIA CANADA CHINA FRANCE GERMANY INDIA ITALY JAPAN LEBANON NETHERLANDS ROMANIA SAUDI ARABIA SPAIN SWEDEN SWITZERLAND UNITED KINGDOM
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0767-2020
- O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Terminated Class II Medical devices
- Recall started
- 1 May 2019
- Terminated
- 19 January 2021
- Reason
- 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 affect the ability to continue use within the operating room until the charger board and/or the batteries are replaced
- Distribution
- Worldwide Distribution - US Nationwide Foreign: ALGERIA AUSTRALIA AUSTRIA BAHRAIN BELGIUM BRAZIL BULGARIA CANADA CANADA CHILE CHINA COLOMBIA CROATIA CZECH REPUBLIC DENMARK EGYPT FINLAND FRANCE GERMANY GREECE HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN K
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1932-2019
- 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 SY
Terminated Class II Medical devices
- Recall started
- 17 September 2018
- Terminated
- 28 May 2020
- Reason
- 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
- Distribution
- Worldwide Distribution - US Nationwide Foreign: AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BRAZIL CANADA CHILE COLOMBIA DENMARK FINLAND FRANCE GERMANY HR ICELAND INDIA IRELAND ISRAEL ITALY JAPAN JORDAN KOREA, REPUBLIC OF LUXEMBOURG MARTINIQUE MEXICO NETHERLANDS NEW ZEAL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0404-2019
- 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
Terminated Class II Medical devices
- Recall started
- 30 August 2018
- Terminated
- 18 June 2020
- Reason
- 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.
- Distribution
- Worldwide - US Distribution in the states: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and Puerto Rico. The products were distributed to the following foreign countr
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0271-2019, Z-0272-2019, Z-0280-2019, Z-0278-2019, Z-0276-2019, Z-0275-2019, Z-0274-2019, Z-0273-2019, Z-0277-2019, Z-0279-2019
- 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
- O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and
- O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D ima
- O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imagin
- O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D i
- O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and
- O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imagin
- O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 25 January 2018
- Terminated
- 1 April 2019
- Reason
- 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.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Puerto Rico. Distributed in Algeria, Australia, Chile, China, Czech Republic, F
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0928-2018
- 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
Terminated Class II Medical devices
- Recall started
- 30 September 2017
- Terminated
- 2 May 2019
- Reason
- 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.
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV., and to the countries of : Australia, Austria
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0927-2018
- 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 weight
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.