Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
This recall has been terminated (originally issued March 17, 2016).
- Recall Initiated
- March 17, 2016
- Terminated
- April 6, 2021
- Recall Number
- Z-2082-2016
- Quantity
- US - 581
- Firm Location
- Littleton, MA
- Official Source
- View on FDA website ↗
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
Nationwide Distribution
Lot / Code Info
Model No. BI-700-00027 and BT-700-00028
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Medtronic's planned action to bring device into Compliance. 1. You will provide an Errata sheet to customers updating the missing and incorrect information. 2. Field Service Engineers (FSEs) will perform radiation output measurements via validated procedures to attain compliance with 21CFR part 1020.32(k)(6). 3. You will inspect and test X-ray generator and system motion batteries for damage, in accordance with the plan submitted to CDRH. Damaged batteries will be replaced. 4. You will update the systems software-based instructions for use by a software update which includes the information supplied by the Errata sheet. For further questions, please call (800) 595-9709.