Recall Z-2311-2012 ยท FSY Light, Surgical, Ceiling Mounted
Trumpf Medical Systems, Inc.
Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
| Date | Sep 5, 2012 (initiated May 29, 2012) |
| Status | Terminated |
| Reason | Cracks can arise on the welded seam on the rear joint. |
| Root cause | Process control |
| Action | 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 rec |
| Quantity | 402 units |
| Distribution | Worldwide Distribution - USA including CA, OH, OK, NY, PA, TX, WY and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061317 | ILED Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg, Jun 22, 2006 |