Helion and Xenion surgical lights — Class II medical device recall Z-0077-2013
Terminated recall by Trumpf Medical Systems, Inc., reported 2012-10-24, distributed nationwide. Incidents regarding fractures of the front joint of the spring arm have been reported.
| Recall number | Z-0077-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trumpf Medical Systems, Inc., Charleston, SC, United States |
| Recall initiated | 2012-09-19 |
| Classified | 2012-10-18 |
| Reported by FDA | 2012-10-24 |
| Terminated | 2014-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 275 units |
| Reason classes | device malfunction |
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 for recall
Incidents regarding fractures of the front joint of the spring arm have been reported.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0077-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.