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

Recall Z-2161-2013 — Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Se

U.S. FDA — Device Enforcement · United States · 2013-07-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2161-2013
Date of alert
2013-07-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the Tec 6 and Tec 6 Plus Vaporizers. The user manual pre-operative check, low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers. If the leak is not detected, it will result in fresh gas leaking to
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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