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Terminated

Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane.

FDA Recall Z-0201-2007 · Posted 2006-11-21

Recalling FirmDatex - Ohmeda, Inc
Recall StatusTerminated
Product CodeCAD
Date Initiated2006-09-15
Date Terminated2007-05-25
Product Quantity93

Reason for Recall

There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer.

Firm Action

An Urgent Medical Device Correction letter dated September 15, 2006, was sent to affected customers. The letter describes the issue, states that a GE representative will contact affected accounts to arrange for the vaporizer exchange at no charge.

Root Cause

Other

Distribution Pattern

Nationwide and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000275DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIADatex-Ohmeda, Inc. · 2000-04-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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