Home / Recalls / Medtronic Navigation, Inc.-Littleton / Z-2082-2016

Z-2082-2016 Class II Terminated

Recalled by Medtronic Navigation, Inc.-Littleton — Littleton, MA

Recall Details

Product Type: Devices
Report Date: July 13, 2016
Initiation Date: March 17, 2016
Termination Date: April 6, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: US - 581

Product Description

Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028

Reason for Recall

It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.

Distribution Pattern

Nationwide Distribution

Code Information

Model No. BI-700-00027 and BT-700-00028

Other recalls by Medtronic Navigation, Inc.-Littleton

Z-2026-2024 Class II — O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D (April 26, 2024)
Z-2449-2023 Class II — The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopi (July 25, 2023)
Z-0767-2020 Class II — O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 (November 15, 2019)
Z-1932-2019 Class II — Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX ( (May 1, 2019)
Z-0404-2019 Class II — Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray s (September 17, 2018)
Z-0275-2019 Class II — O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Mode (August 30, 2018)
Z-0273-2019 Class II — O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Mode (August 30, 2018)
Z-0271-2019 Class II — O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Mode (August 30, 2018)
Z-0280-2019 Class II — O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFU (August 30, 2018)
Z-0276-2019 Class II — O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V (August 30, 2018)