Z-1237-2008

International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220

Name: Z-1237-2008 International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220
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 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220 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-1237-2008
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 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220
Product code: DQA Oximeter
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: 7 units
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: 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.

Product code DQA

K922075Class IIAvoximeterA-Vox Systems, Inc. / cleared 1992-11-04

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)