Device recall
Z-0607-2012: SKYLight Imaging Systems, Model 882050; Intended to produce images depicting the…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-0607-2012 |
|---|---|
| Recall event | 60660 |
| Product | SKYLight Imaging Systems, Model 882050; Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. |
| Product code | KPS |
| Recalling firm | Philips Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 13, 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