International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220
FDA device recall Z-1239-2008 · posted 2008-08-06 · Terminated
Recall details
- Recalling firm
- International Technidyne Corp.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JKS
- Quantity affected
- 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,
- Date initiated
- 2008-02-13
- Date posted
- 2008-08-06
- Date terminated
- 2009-07-24
- Location
- Edison, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AVOXIMETER 4000 (K951485) | A-Vox Systems, Inc. | 1995-11-06 |