Recall Z-1188-2008 ยท DQA Oximeter
Kentec Medical Inc
Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care. Kentec Medical Inc., Irvine, CA 92614
| Date | Jun 26, 2008 (initiated May 18, 2007) |
| Status | Terminated |
| Reason | Incompatible components: The Finger Clip Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 - are missing an additional diode and higher resistor in its existing configuration making them inoperable when used to interface with those Ohmeda Tuffsat monitors previously re-configured by Ohmeda to include a detection circuit for diodes. |
| Root cause | Process change control |
| Action | Consignees were notified via telephone on 5/18/07 and an "Important Voluntary Market Withdrawal Notice" letter on 5/23/07. The letter instructed consignees to segregate and return all affected devices. The letter included an "Acknowledgement of Market Withdrawal Notification" form for customer to complete and return to the recalling firm. For additional information, contact 1-800-825-5996. |
| Quantity | 41 |
| Distribution | Nationwide Distribution including states of AZ, CA, CO, FL, KY, LA, MA, NC, NJ, TX and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970098 | E100 SERIES SPO2 SENSORS Epic Medical Equipment Services, Inc., Apr 30, 1998 |