Device recall
Z-0753-2016: GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended…
FDA device recall · Class II · Regulatory Insight, Inc
Key facts
| Recall number (Z-number) | Z-0753-2016 |
|---|---|
| Recall event | 72515 |
| Product | GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. |
| Product code | OWB |
| Recalling firm | Regulatory Insight, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2017 |
| 510(k) numbers | K033486 |
| FEI number | 3011361886 |
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