Chromophare Surgical Light System , REF CH00000001
FDA Recall Z-1506-2024 · Posted 2024-04-09
Recalling FirmStryker Communications
Recall StatusOpen, Classified
Product CodeFSY
Date Initiated2024-02-08
Product Quantity1 unit
Reason for Recall
Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
Firm 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
[email protected].
4. A Sales Representative or Field Service Technician will be in contact with your facility to schedule a service visit to
perform the recall activities.
5. Maintain awareness of this communication internally until all required actions have been completed within your
facility. Response is required.
Root Cause
Employee error
Distribution Pattern
US: None OUS: Chili
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.