Device recall
Z-1392-2018: Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated…
FDA device recall · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Recall number (Z-number) | Z-1392-2018 |
|---|---|
| Recall event | 79696 |
| Product | Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human… |
| Product code | KPS |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 21, 2019 |
| 510(k) numbers | K052640 |
| FEI number | 1525965 |
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