Recall Z-0466-06 ยท FLL Continuous Measurement Thermometer
Omron Healthcare, Inc.
Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used to take an accurate patient temperature measurement in 4-6 seconds typically in the oral, rectal or under arm modes when the ambient temperature is between 50 degrees F and 93.2 degrees F; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061, Made in Philipp
| Date | Feb 4, 2006 (initiated Oct 25, 2005) |
| Status | Terminated |
| Reason | Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip. |
| Root cause | Other |
| Action | Omron sent recall letters dated 10/21/05 to all of their direct accounts, informing them that the probe tip could overheat and possibly burn the person whose temperature is being taken. The accounts were instructed to check the lot number on their thermometers immediately to see if they fall within the range of affected thermometers (lots beginning with 01-32, 01-36, 01-37 and 01-38). The accounts were instructed to call Omron at 1-800-634-4350 if their unit is affected to get instructions on how to return the unit to Omron for a refund. Omron issued a press release on 10/24/05 to alert con |
| Quantity | Approximately 48,000 units |
| Distribution | Nationwide and internationally to Canada, Chile, Venezuela and Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983887 | UP-GRADE AND UP-GRADE PRO Medisim, Ltd., Feb 12, 1999 |