Device recall
Z-1061-2017: Velara Generator with an old Firmware version used with Philips Allura Xper…
FDA device recall · Class II · Philips Electronics North America Corporation
Key facts
| Recall number (Z-number) | Z-1061-2017 |
|---|---|
| Recall event | 76080 |
| Product | Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane) |
| Product code | IZI |
| Recalling firm | Philips Electronics North America Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 30, 2020 |
| 510(k) numbers | K033737, K041949 |
| FEI number | 1218950 |
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