Recall Z-2083-2016 ยท OWB Interventional Fluoroscopic X-Ray System
Medtronic Navigation, Inc.-Littleton
Medtronic Navigation O-arm 02 surgical x-ray imaging system
| Date | Mar 17, 2016 |
| Status | Terminated |
| Reason | 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). |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | US - 63 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151000 | O-Arm O2 Imaging System Medtronic, Inc., Aug 6, 2015 |