Device recall
Z-2245-2020: Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-2245-2020 |
|---|---|
| Recall event | 85560 |
| Product | Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an… |
| Product code | MWI |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 14, 2023 |
| 510(k) numbers | K080038 |
| FEI number | 1218950 |
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