Device recall
Z-2248-2018: Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Recall number (Z-number) | Z-2248-2018 |
|---|---|
| Recall event | 80200 |
| Product | Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution… |
| Product code | JAK |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2020 |
| 510(k) numbers | K173578 |
| FEI number | 1000514697 |
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