FDA Device recall Z-0077-2013
Helion and Xenion surgical lights, 501/01 series KLM lights
- FDA Device
- Class II
- terminated
- Published 2012-10-24
On 2012-10-24 the FDA classified a Class II recall of Helion and Xenion surgical lights, 501/01 series KLM lights by Trumpf Medical Systems, citing incidents regarding fractures of the front joint of the spring arm have been reported.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0077-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-19 |
| Published | 2012-10-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Trumpf Medical Systems |
| Distribution | US |
Product
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.
Reason
Incidents regarding fractures of the front joint of the spring arm have been reported.
Identifiers
| code_info | Ondal AC2000 serial range of the spring arms requiring rework: 0111 010 xxxxxx to 0111 066 xxxxx (010 to 066 = month 01…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). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Trumpf Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0077-2013%22
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