International Technidyne Corp. (ITC) AVOXimeter 1000… recallZ-1237-2008 · International Technidyne Corp. · initiated Feb 13, 2008
Terminated All recalls posted in August 2008
Is my device affected?
- 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.
- If yours is listed, follow the instructions from International Technidyne Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.
FDA root cause category: Process design
What the company is doing
ITC sent Urgent - Medical Device Field Recall - ITC No. 08-001 letters dated 2/08/2008 to hospitals and/or medical facilities identified as having affected instruments. The letter instructed users not to use the instrument if the diagnostic mode is enabled. ITC will reset affected devices and return them to the customers.
Recall details
- Recall number
- Z-1237-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 13, 2008
- Posted by the FDA
- Aug 6, 2008
- Recalling firm
- International Technidyne Corp.
- Quantity
- 7 units
- Product code
- DQA
- FDA submissions
- K922075
- Distribution
- Worldwide Distribution: USA, United Arab Emirates, Malaysia, Saudi Arabia, India, Germany, United Kingdom, Greece, Romania, Singapore, ROC, Pakistan, Netherlands, Korea, France, Belgium, Switzerland, Canada, Thailand, Slovenia, Turkey and Australia.
Product description
International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220
Code information (models, lots, serial numbers)
Serial Numbers: 1073, 1085, 1197, 1245, 1321, 1383, 1162. Catalog Numbers/Code: AVON1000-110 and AVOX-1000-220. Note:w The AVOXimeter 1000 was discontinued in 1996 by the company which which ITC acquired the product line from (AVOX Systems in Texas. Today, only service is offered on this mode.
Other devices under the same FDA submission
2 devices cleared under K922075 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Avoximeter Whole Blood Oximeter AVOX1000EAccriva Diagnostics Holdings, Inc. · Oximeter1 recall0 reports
- Avoximeter Whole Blood Oximeter C100BAccriva Diagnostics Holdings, Inc. · Oximeter1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 46773).
- Z-1238-2008 · TerminatedInternational Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers: AVOX1000E-110 and AVOX1000E-220
- Z-1239-2008 · TerminatedInternational Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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