Recall archive / FDA device enforcement
interventional fluoroscopic x-ray system — FDA record Z-2021-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 15, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2021-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 4056869295923 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 9, 2025
- Recall initiation date
- May 15, 2025
- Center classification date
- Jun 27, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.