Device recall
Z-0326-2008: Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini…
FDA device recall · Class II · Mini-Mitter Company, Inc.
Key facts
| Recall number (Z-number) | Z-0326-2008 |
|---|---|
| Recall event | 38368 |
| Product | Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a Respironics Company, Bend, Oregon |
| Product code | M |
| Recalling firm | Mini-Mitter Company, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 20, 2010 |
| 510(k) numbers | K983533 |
| FEI number | 3007223238 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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