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Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an… recallZ-0201-2007 · Datex - Ohmeda, Inc · initiated Sep 15, 2006

Terminated All recalls posted in November 2006

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Datex - Ohmeda, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0201-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 15, 2006
Posted by the FDA
Nov 21, 2006
Recalling firm
Datex - Ohmeda, Inc
Quantity
93
Product code
CAD
FDA submissions
K000275
Distribution
Nationwide and Canada.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

serial numbers: AETK25021 thru AETK25023, AETK25024, AETK25025, AETK25027 thru AETK25030, AETK27001, AETK27002, AETK27004, AETK27006, AETK27007, AETK27010 thru AETK27015, AETK27017, AETK27019, AETK27020, AETK27024, AETK27025, AETK27027, AETK27031 thru AETK27034, AETK27039, AETK27040, AETK28001 thru AETK28003, AETK28005, AETK28006, AETK28008, AETK28010, AETK28011, AETK28013 thru AETK28017, AETK28019, AETK28021, AETK28023 thru AETK28025, AETK28029, AETK28031thru AETK28038, AETK28040 thru AETK28046, AETK28048, AETK28050 thru AETK28052, AETK28056, AETK28057, AETK28059, AETK28063, AETK28065, AETK28067, AETK28070 thru AETK28072, AETK28074 thru AETK28076, AETK29004, AETK29006, AETK29035, AETK29037, AETK29039, AETK29043, AETK29045, AETK29061, AETK29068, AETK29073, AEWK30001.

Other devices under the same FDA submission

3 devices cleared under K000275 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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