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

Recall Z-0930-2015 — Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.

U.S. FDA — Device Enforcement · United States · 2014-11-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0930-2015
Date of alert: 2014-11-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Steris Corporation
Product category: device
Product type: Devices

Reported risk: STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.

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.

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