Recall Z-0692-2018 ยท FSY Light, Surgical, Ceiling Mounted
Stryker Communications
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
| Date | Jan 26, 2018 |
| Status | Terminated |
| Reason | The mounts on the monitor may have an insufficient (missing or incomplete) weld. |
| Root cause | Process control |
| Action | The recalling firm issued letters dated 1/26/2018 via FedEx on 1/26/2018 explaining the issue and the potential adverse consequences. |
| Quantity | 850 |
| Distribution | Distribution was made to medical facilities nationwide, including government and military distribution. Foreign distribution was made to Canada, Belgium, China, United Kingdom, UAE, France, Germany, Spain, Japan, Ecuador, and Russia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.