Z-2021-2025 Class II Ongoing
FDA device recall Z-2021-2025 was initiated by Siemens Medical Solutions USA, Inc on May 15, 2025 and is designated Class II. Reason for recall: 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 appl… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2025
- Initiation Date
- May 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
Product Description
interventional fluoroscopic x-ray system
Reason for Recall
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.
Distribution Pattern
Worldwide.
Code Information
4056869295923