Device recall
Z-1291-2010: REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product. Intended…
FDA device recall · Class II · Philips Healthcare Inc.
Key facts
| Recall number (Z-number) | Z-1291-2010 |
|---|---|
| Recall event | 53869 |
| Product | REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care. |
| Product code | BZC |
| Recalling firm | Philips Healthcare Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 8, 2016 |
| 510(k) numbers | K963380 |
| FEI number | 1218950 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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