Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0077-2013 — 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.

U.S. FDA — Device Enforcement · United States · 2012-09-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0077-2013
Date of alert: 2012-09-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Trumpf Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: Incidents regarding fractures of the front joint of the spring arm have been reported.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0077-2013 — 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 patients body with a high intensity light.

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Recall Z-0077-2013 — 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.