Z-1239-2008

International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and...

Name: Z-1239-2008 International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and...
Creator: International Technidyne Corp.
Published: 2008-02-13
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2008-02-13 / Terminated / root cause: manufacturing process

FDA source

International Technidyne Corp. began a recall of International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220 on 2008-02-13. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1239-2008
Status: Terminated
Initiated: 2008-02-13
Posted: 2008-08-06
Terminated: 2009-07-24
Recalling firm: Accriva Diagnostics, Inc.
Product: International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220
Product code: JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 61 US, 2 International
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 codes and lots: 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.

Product code JKS

K951485Class IAvoximeter 4000A-Vox Systems, Inc. / cleared 1995-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)