Device recall
Z-0562-2018: Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is…
FDA device recall · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Recall number (Z-number) | Z-0562-2018 |
|---|---|
| Recall event | 79008 |
| Product | Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray… |
| Product code | JAK |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 30, 2022 |
| 510(k) numbers | K172406 |
| 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