Recall Z-1506-2024 ยท FSY Light, Surgical, Ceiling Mounted
Stryker Communications
Chromophare Surgical Light System , REF CH00000001
| Date | Apr 9, 2024 (initiated Feb 8, 2024) |
| Status | Open, Classified |
| Reason | Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. |
| Root cause | Employee error |
| Action | On February 19, 2024, Stryker issued a Urgent Medical Device Recall notification via XXX. In addition to notifying consignees about the recall. Stryker asked consignees to take the following actions: Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the product listed in the product affected grid. If affected product is found, segregate and do not use the product. 3. Complete and sign the enclosed Business Reply Form on Attachment A and return to CommunicationsRA1@stryker.com. 4. A Sales Representative or Field Service |
| Quantity | 1 unit |
| Distribution | US: None OUS: Chili |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120392 | CHROMOPHARE F 628 AND F 528 Berchtold GmbH & Co. KG, Feb 16, 2012 |