Recall Z-1239-2008 ยท JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
International Technidyne Corp.
International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220
| Date | Aug 6, 2008 (initiated Feb 13, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951485 | AVOXIMETER 4000 A-Vox Systems, Inc., Nov 6, 1995 |