Device recall
Z-0597-2017: Ingenuity Core Computed Tomography X-ray system, Model 728321
FDA device recall · Class III · Philips Medical Systems (Cleveland) Inc
Key facts
| Recall number (Z-number) | Z-0597-2017 |
|---|---|
| Recall event | 75516 |
| Product | Ingenuity Core Computed Tomography X-ray system, Model 728321 |
| Product code | JAK |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 29, 2018 |
| 510(k) numbers | K160743 |
| 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