Recall Z-1602-2020 ยท FSY Light, Surgical, Ceiling Mounted
Stryker Communications
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
| Date | Oct 11, 2019 |
| Status | Terminated |
| Reason | The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients. |
| Root cause | Other |
| Action | On October 11, 2019, a "Urgent Medical Device Correction" letter was sent to all affected customers via FedEx. In addition to explaining the recall, the recall letter as customers to take the following action: Please assure this notification letter is disseminated within your organization. A Stryker Representative will begin scheduling visits to customer facilities to perform inspections. This correction is expected to last one year. During the inspection, the Stryker Representative will perform a visual inspection on the lower portion of the Chromophare Ceiling Mounted Surgical Light Suspens |
| Quantity | 1415 Surgical Lights |
| Distribution | US: Nationwide OUS: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.