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FDA (Device enforcement)Recalled 2012-05-29closedclass ii

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 l

Is my product affected?

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.

  • UPC 011201602557
  • UPC 011201602588
  • UPC 011203602617
  • UPC 011202602621
  • UPC 011203602676
  • UPC 011203602695
  • UPC 011203602756
  • UPC 011203602775
  • UPC 011203602776
  • UPC 011203602795
  • UPC 011204602798
  • UPC 011204602817
  • UPC 011204602861
  • UPC 011204602880
  • UPC 011204602970
  • UPC 011204602989
  • UPC 011205603032
  • UPC 011205603081
  • UPC 011206603118
  • UPC 011206603167
  • UPC 011206603168
  • UPC 011206603217
  • UPC 011207603303
  • UPC 011207603314
  • UPC 011208603316
  • UPC 011205603333
  • UPC 011208603361
  • UPC 011209603431
  • UPC 011209603462
  • UPC 011210603572
  • UPC 011210603597

Check against the official notice below — it lists the full affected range.

What happened

Trumpf Medical Systems, Inc. is recalling the Acrobat 3000 (AC3000) Spring Arm, which is used as a support arm for iLED operating lights. The recalled units were distributed worldwide, including throughout the United States (California, Ohio, Oklahoma, New York, Pennsylvania, Texas, and Wyoming) and Canada. A total of 402 units are affected, identified by nameplate I.D. "FA AC3" or "FA AC3000" with specific material and serial numbers listed in the recall notice.

The reason for the recall is that cracks can develop on the welded seam at the rear joint of the spring arm. The recall record does not specify a remedy or what consumers should do in response.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Cracks can arise on the welded seam on the rear joint.

Details from the source

Reason for recall: Cracks can arise on the welded seam on the rear joint. Distribution: Worldwide Distribution - USA including CA, OH, OK, NY, PA, TX, WY and the country of Canada Quantity: 402 units Lot/code info: I.D. on nameplate: FA AC3 or FA AC3000; Material #1920632, Serial #011201602557 to 011201602588; Serial #011203602617 to 011202602621; Serial #011203602676 to 011203602695; Serial #011203602756 to 011203602775; Serial #011203602776 to 011203602795; Serial #011204602798 to 011204602817; Serial #011204602861 to 011204602880; Serial #011204602970 to 011204602989; Serial #011205603032 to 011205603081; Serial #011206603118 to 011206603167; Serial #011206603168 to 011206603217; Serial #011207603303 to 011207603314; Serial #011208603316 to 011205603333; Serial #011208603361 - Serial #011209603431 to 011209603462; Serial #011210603572 to 011210603597 and Material #1851710, Serial #3705776 to 3705777 and Serial #4105778 to 4105781.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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