Device recall
Z-0215-2020: Forte Gamma Camera System is intended to produce images depicting the anatomical…
FDA device recall · Class I · Philips Medical Systems (Cleveland) Inc
Key facts
| Recall number (Z-number) | Z-0215-2020 |
|---|---|
| Recall event | 84009 |
| Product | Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel. |
| Product code | KPS |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 5, 2021 |
| 510(k) numbers | K033254 |
| 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