Recall Z-1060-2017 ยท OWB Interventional Fluoroscopic X-Ray System
GE OEC Medical Systems, Inc
OEC 9900 Elite. MDL Numbers: D148942, D155043
| Date | Jan 20, 2017 (initiated Dec 27, 2016) |
| Status | Terminated |
| Reason | GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies. |
| Root cause | Packaging change control |
| Action | The customer communication is expected to begin distribution in January 2017. Consignees will be notified of the availability of the Operator Manual supplement via a letter. No product is being returned. |
| Quantity | 26,256 total |
| Distribution | Worldwide including govt/VA/military and foreign consignees. |
| FDA record | Open on fda.gov |