interventional fluoroscopic x-ray system
Reported: July 9, 2025 Initiated: May 15, 2025 #Z-2022-2025
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Distribution
- Worldwide.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
interventional fluoroscopic x-ray system. Recalled by Siemens Medical Solutions USA, Inc.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 9, 2025. Severity: Moderate. Recall number: Z-2022-2025.
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