Device recall
Z-2388-2016: EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60…
FDA device recall · Class II · Edan Diagnostics
Key facts
| Recall number (Z-number) | Z-2388-2016 |
|---|---|
| Recall event | 74632 |
| Product | EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors… |
| Product code | MHX |
| Recalling firm | Edan Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 16, 2016 |
| 510(k) numbers | K110922, K113623, K113653, K131971 |
| FEI number | 3009499478 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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