Siemens Interventional X-ray System May Misreport Radiation Dose
Siemens interventional fluoroscopic x-ray systems may fail to correctly measure and report radiation dose due to rare sensor-software communication failures. The worldwide recall affects healthcare facilities using these systems.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves a risk-of-harm product (radiation dose measurement) where injury has not yet been reported. Although the source describes the failure as very rare and provides no evidence of reported illnesses or injuries, the potential for incorrect radiation dose in a medical x-ray system presents a credible risk to patient safety.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling its interventional fluoroscopic x-ray systems worldwide.
In very rare situations, communication between the sensor that measures radiation dose and the corresponding software fails. When this occurs, the system may incorrectly report the amount of radiation dose applied to the patient or treatment area.
This Class II recall was issued by the U.S. Food and Drug Administration. Healthcare facilities and medical professionals using these systems should be aware of this potential failure mode.
The recalled product
- Product
- interventional fluoroscopic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- dose-measurement-error
- incorrect-dose-reporting
- sensor-software-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 4056869063317
Distribution
Distribution scope not specified by the agency.
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