Medtronic Navigation O-arm 02 surgical x-ray imaging system
This recall has been terminated (originally issued March 17, 2016).
- Recall Initiated
- March 17, 2016
- Terminated
- April 6, 2021
- Recall Number
- Z-2083-2016
- Quantity
- US - 63
- Firm Location
- Littleton, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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).
Distribution
Nationwide Distribution
Lot / Code Info
model number BT-700-02000
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Medtronic planned action to bring device into Compliance: 1. You will contact customers and provide an Errata sheet to them updating the missing and incorrect information. 2. Medtronic field service personnel will perform radiation output measurements via validated procedures to attain compliance with 21CRF part 1020.32(k)(6). 3. You will update the systems software-based instructions for use by a software update which includes the information supplied by the Errata sheet. For questions call (800)-595-9709.