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.
FDA Recall Z-2311-2012 · Posted 2012-09-05
Advertisement
Recalling FirmTrumpf Medical Systems, Inc.
Recall StatusTerminated
Product CodeFSY
Date Initiated2012-05-29
Date Terminated2013-04-11
Product Quantity402 units
Reason for Recall
Cracks can arise on the welded seam on the rear joint.
Firm 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 receipt.
For questions regarding this recall call 888-474-9359.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA including CA, OH, OK, NY, PA, TX, WY and the country of Canada
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.
Advertisement