Device recall
Z-0462-2008: Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems, diagnostic…
FDA device recall · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Recall number (Z-number) | Z-0462-2008 |
|---|---|
| Recall event | 44934 |
| Product | Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems, Philips Medical Systems, Cleveland, OH 44143 |
| Product code | KPS |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 2, 2012 |
| 510(k) numbers | K051170, 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