International Technidyne Corp. (ITC) AVOXimeter 4000… recallZ-1239-2008 · 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-1239-2008
- 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
- 61 US, 2 International
- Product code
- JKS
- FDA submissions
- K951485
- 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 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
41018 41068 41096 41124 41146 41175 41280 41323 41325 41384 41423 41430 41453 41480 41484 41489 41505 41506 41532 41533 41555 41560 41566 41570 41571 41572 41573 41574 41575 41576 41577 41578 41578 41579 41580 41581 41582 41582 41583 41584 41585 41586 41588 41589 41592 41593 41594 41595 41601 41605 41607 41608 41609 41610 41611 41612 41613 41614 41615 41616 41617 41618 41619 41620 41632 41633 41634 41635 41636 41637 41638 41639 Q-1034 Catalog/Code Numbers: AVOX4000-110 and AVOX4000-220.
Other devices under the same FDA submission
1 device cleared under K951485 — 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 CO-Oximeter AVOX4000Accriva Diagnostics Holdings, Inc. · Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 46773).
- Z-1237-2008 · TerminatedInternational Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220
- Z-1238-2008 · TerminatedInternational Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers: AVOX1000E-110 and AVOX1000E-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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