Device recall
Z-0704-2018: digital x-ray detector ProGrade R1 - solid state X ray imager (flat…
FDA device recall · Class II · Philips Electronics North America Corporation
Key facts
| Recall number (Z-number) | Z-0704-2018 |
|---|---|
| Recall event | 79139 |
| Product | digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for all routine radiographic… |
| Product code | MQB |
| Recalling firm | Philips Electronics North America Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 29, 2020 |
| 510(k) numbers | K141736 |
| 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