Device recall
Z-0260-2016: GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-0260-2016 |
|---|---|
| Recall event | 72301 |
| Product | GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information, acquired simultaneously and… |
| Product code | OUO |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 7, 2018 |
| 510(k) numbers | K142098 |
| FEI number | 2126677 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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