FDA Medical devices recall ·
interventional fluoroscopic x-ray system recall
- Recall number
- Z-2021-2025
- Date
- (initiated May 15, 2025)
- Company / brand
- Siemens Medical Solutions USA, Inc
40 Liberty Blvd, Malvern, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Hazard tags
- Software
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
interventional fluoroscopic x-ray system
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
4056869295923
Distribution
Worldwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2021-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.