Device recall
Z-0466-06: Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN…
FDA device recall · Class II · Omron Healthcare, Inc.
Key facts
| Recall number (Z-number) | Z-0466-06 |
|---|---|
| Recall event | 33801 |
| Product | 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… |
| Product code | FLL |
| Recalling firm | Omron Healthcare, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 28, 2007 |
| 510(k) numbers | K983887 |
| FEI number | 1450057 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database