Enforcement Report - Week of October 24, 2012
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Product Detail
| Product Description | Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light. |
|---|---|
| Recall Number | Z-0077-2013 |
| Classification | Class II |
| Code Info | Ondal AC2000 serial range of the spring arms requiring rework: 0111 010 xxxxxx to 0111 066 xxxxx (010 to 066 = month 01/year 20000 to month 06/year 2006 xxxxxx = 5 digit serial number). |
| Product Distributed Qty | 275 units |
| Reason For Recall | Incidents regarding fractures of the front joint of the spring arm have been reported. |
Event Detail
| Event Id | 63255 |
|---|---|
| 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 | 2012-09-19 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT and WI. |
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