Recall Z-2218-2011 ยท DQA Oximeter
International Technidyne Corp.
AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use int he cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemogl
| Date | May 19, 2011 (initiated Mar 23, 2011) |
| Status | Terminated |
| Reason | An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments. |
| Root cause | Device Design |
| Action | International Technidyne Corp. sent a letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory to determine if they have any of the affected product. If they have any of the affected product, customers were instructed to stop using it and remove it from their inventory. Customers were also instructed to complete the attached Customer Account Tracking Form and return it by fax to (732-635-0144) or e-mail (techsupport@itcmed.com) or mail to: ITC Techn |
| Quantity | 17 |
| Distribution | Worldwide Distribution - USA including TX, KS, OH, OR, FL, GA, NY, MA, and DC and the countries of Taiwan and Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951485 | AVOXIMETER 4000 A-Vox Systems, Inc., Nov 6, 1995 |