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.
Recall
- Recall Number
- Z-2311-2012
- Event Number
- 62593
- Firm
- Trumpf Medical Systems, Inc.
- FEI Number
- 3003184737
- Product Code
- FSY
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- May 29, 2012
- Posted
- September 5, 2012
- Terminated
- April 11, 2013
- Address
- 415 Jessen Ln, Charleston, SC, 29492
Description
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.
Cracks can arise on the welded seam on the rear joint.
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.
Worldwide Distribution - USA including CA, OH, OK, NY, PA, TX, WY and the country of Canada
402 units