Device recall
Z-0257-2012: Precedence System; SYST,PRECEDENCE, 6 SLICE 3/8 Manufactured by Philips Medical…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-0257-2012 |
|---|---|
| Recall event | 60021 |
| Product | Precedence System; SYST,PRECEDENCE, 6 SLICE 3/8 Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes… |
| Product code | KPS |
| Recalling firm | Philips Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2012 |
| 510(k) numbers | K041218 |
| FEI number | 1525965 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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