Device recall
Z-1425-2017: Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile…
FDA device recall · Class II · Siemens Medical Solutions USA Inc.
Key facts
| Recall number (Z-number) | Z-1425-2017 |
|---|---|
| Recall event | 76228 |
| Product | Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining… |
| Product code | KPS |
| Recalling firm | Siemens Medical Solutions USA Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 17, 2017 |
| 510(k) numbers | K141971 |
| FEI number | 1034973 |
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