Device recall
Z-1322-2023: Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11…
FDA device recall · Class I · Philips Respironics, Inc.
Key facts
| Recall number (Z-number) | Z-1322-2023 |
|---|---|
| Recall event | 91837 |
| Product | Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. |
| Product code | BZD |
| Recalling firm | Philips Respironics, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K131982 |
| FEI number | 2518422 |
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