Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puch
FDA device recall Z-2311-2012 · posted 2012-09-05 · Terminated
Recall details
- Recalling firm
- Trumpf Medical Systems, Inc.
- Reason for recall
- Cracks can arise on the welded seam on the rear joint.
- Action taken
- TRUMPF sent an Urgent Safety Information letter dated February 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that within their organization, all users of the affected product be informed about the Urgent Safety Information. If affected product was further distributed, customers should forward a copy of the information or inform the necessary parties. Customers were asked to confirm receipt of the Urgent Safety Information by completing and returning the confirmation of receipt. For questions regarding this recall call 888-474-9359.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 402 units
- Distribution
- Worldwide Distribution - USA including CA, OH, OK, NY, PA, TX, WY and the country of Canada
- Date initiated
- 2012-05-29
- Date posted
- 2012-09-05
- Date terminated
- 2013-04-11
- Location
- Charleston, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ILED (K061317) | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006-06-22 |