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Terminated

International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220

FDA Recall Z-1239-2008 · Posted 2008-08-06

Recalling FirmInternational Technidyne Corp.
Recall StatusTerminated
Product CodeJKS
Date Initiated2008-02-13
Date Terminated2009-07-24
Product Quantity61 US, 2 International

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.

Firm 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.

Root Cause

Process design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K951485AVOXIMETER 4000A-Vox Systems, Inc. · 1995-11-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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