Summary
The FDA issued a Class II for interventional fluoroscopic x-ray system by Siemens Medical Solutions USA, Inc. 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 .
Details
Source
Device Recall
External ID
Z-2020-2025
Action Date
2025-07-09
Status
Ongoing
Category
device
Product Description
interventional fluoroscopic x-ray system
Lot/Code Info: 4056869063317
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
Worldwide.
Type: FDA Mandated
Recall Initiated: 2025-05-15
Company
Malvern, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Medical Solutions USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Medical Solutions USA, Inc have FDA actions?
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2020-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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