Chromophare Surgical Light System , REF CH00000001
FDA device recall Z-1506-2024 · posted 2024-04-09 · Open, Classified
Recall details
- Recalling firm
- Stryker Communications
- Reason for recall
- Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
- Action taken
- 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 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
- Status
- Open, Classified
- Product code
- FSY
- Quantity affected
- 1 unit
- Distribution
- US: None OUS: Chili
- Date initiated
- 2024-02-08
- Date posted
- 2024-04-09
- Location
- Flower Mound, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHROMOPHARE F 628 AND F 528 (K120392) | Berchtold GmbH & Co. KG | 2012-02-16 |