Device recall
Z-0286-2010: Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which…
FDA device recall · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Recall number (Z-number) | Z-0286-2010 |
|---|---|
| Recall event | 50135 |
| Product | Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems: GEMINI GXL 16 slice configuration, Model Number: 4535 679 75691. |
| Product code | JAK |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 24, 2010 |
| 510(k) numbers | K033357, K051170 |
| 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