Device recall
Z-1053-2019: Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-1053-2019 |
|---|---|
| Recall event | 82313 |
| Product | Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cystography Cystoscopy, endopscopy… |
| Product code | IXR |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2020 |
| 510(k) numbers | K911098 |
| 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