Device recall
Z-0398-2011: SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-0398-2011 |
|---|---|
| Recall event | 57029 |
| Product | SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535 600 66661; and 5/8" SPECT, Model number 4535 602 20381, manufactured by Philips Medical Systems (Cleveland), Cleveland OH. Intended to produce images depicting the anatomical distributions of… |
| Product code | KPS |
| Recalling firm | Philips Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2012 |
| 510(k) numbers | K000908 |
| 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