Device recall
Z-0078-2027: Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.)…
FDA device recall · Class II · PHILIPS MEDICAL SYSTEMS
Key facts
| Recall number (Z-number) | Z-0078-2027 |
|---|---|
| Recall event | 99796 |
| Product | Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.); |
| Product code | JAK |
| Recalling firm | PHILIPS MEDICAL SYSTEMS |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K244008 |
| FEI number | 3017726341 |
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