Recall Z-2446-2019 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 | Aug 30, 2019 (initiated Aug 1, 2019) |
| Status | Terminated |
| Reason | The mounts on the monitor may have an insufficient weld. |
| Root cause | Process control |
| Action | The recalling letter issued letters on 8/1/2019 via Fed Ex. |
| Quantity | 52 devices |
| Distribution | Distribution was made to CA, CO, CT, FL, GA, IL, IN, MD, MI, MN, MO, NC, NH, NJ, NY, OH, PA, SC, TN, TX, and WI. There was foreign distribution to Canada and Germany. There was no government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.