FDA Device recall Z-2021-2025
interventional fluoroscopic x-ray system
- FDA Device
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of interventional fluoroscopic x-ray system by Siemens Medical Solutions Usa, citing in very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incor….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2021-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-15 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
interventional fluoroscopic x-ray system
Reason
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Identifiers
| code_info | 4056869295923 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2021-2025%22
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