Device product

interventional fluoroscopic x-ray system

Z-2021-2025

May 15, 2025

Class II

Product summary

Firm: Siemens Medical Solutions USA, Inc
Event: Event 97135
Status: Ongoing
Classification: Class II
Quantity: Unavailable
Official record key: device-enforcement:Z-2021-2025

Official wording

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.

Code information: 4056869295923

Distribution pattern: Worldwide.

Derived failure modes

Device software or design
reason.device_software_design · v1.0.0

software fails. As a result of the failure