Enforcement Report - Week of September 12, 2012
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Event Detail
| Event ID | 62593 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Trumpf Medical Systems, Inc. |
| City | Charleston |
| State | SC |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-29 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA including CA, OH, OK, NY, PA, TX, WY and the country of Canada |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | 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. | Class II | Cracks can arise on the welded seam on the rear joint. | 402 units | Z-2311-2012 |
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