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U.S. Department of Health and Human Services

Class 2 Device Recall Acrobat 3000 (AC3000) Spring Arm

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  Class 2 Device Recall Acrobat 3000 (AC3000) Spring Arm see related information
Date Initiated by Firm May 29, 2012
Date Posted September 05, 2012
Recall Status1 Terminated 3 on April 11, 2013
Recall Number Z-2311-2012
Recall Event ID 62593
510(K)Number K061317  
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Trumpf Medical Systems, Inc.
415 Jessen Ln
Charleston SC 29492
For Additional Information Contact Lindsey Ronnenberg
888-474-9359
Manufacturer Reason
for Recall		 Cracks can arise on the welded seam on the rear joint.
FDA Determined
Cause 2		 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 receipt. For questions regarding this recall call 888-474-9359.
Quantity in Commerce 402 units
Distribution Worldwide Distribution - USA including CA, OH, OK, NY, PA, TX, WY and the country of Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FSY and Original Applicant = TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG
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