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

Recall Z-1277-2013 — Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunct

U.S. FDA — Device Enforcement · United States · 2009-11-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1277-2013
Date of alert: 2009-11-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Olympus America Inc.
Product category: device
Product type: Devices

Reported risk: Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to operate associated with the Olympus SurgMaster electrosurgical unit, model UES-40 ("UES-40") when used in conjunction with the Olympus WA22557C electrode. The complaint investigations revealed that

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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