FDA Device recall Z-0810-2015
Biograph mCT S(64)-4R, System Material Number 10248672
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of Biograph mCT S(64)-4R, System Material Number 10248672 by Siemens Medical Solutions Usa, citing possibility for system display freeze during CT interventional procedures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0810-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-13 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | MA, NC |
Product
Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Reason
Possibility for system display freeze during CT interventional procedures.
Identifiers
| code_info | Serial Number: 11021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0810-2015%22
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