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

Recall Z-2134-2016 — Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope

U.S. FDA — Device Enforcement · United States · 2016-06-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2134-2016
Date of alert
2016-06-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Karl Storz Endoscopy
Product category
device
Product type
Devices
Reported risk: Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope and an electro-surgery generator (ESG).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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