Device recall
Z-0013-2007: Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models #…
FDA device recall · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Recall number (Z-number) | Z-0013-2007 |
|---|---|
| Recall event | 37567 |
| Product | Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems. |
| Product code | KPS |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2010 |
| 510(k) numbers | K041955, K042935 |
| 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