Siemens RAD Fluoro Uro System Recalled for Radiation Malfunction
Siemens is recalling 59 RAD Fluoro Uro systems because a software malfunction can cause radiation to continue longer than required, resulting in overexposed images.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (excessive radiation exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 59 units of the RAD Fluoro Uro system, specifically the Luminos dRF and Uroskop Omnia models with software version VD10A/G. The affected units were distributed nationwide in the United States and internationally to Canada.
The recall is due to a malfunction that can occur during RAD examinations. This issue may cause radiation to continue longer than required, resulting in an overexposed image that is not of diagnostic quality. This failure prompts the repetition of the examination.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this issue.
The recalled product
- Product
- Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 59
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)
- Model numbers 10094910 and 10094200 with software version VD10A/G.
Distribution
Distributed nationwide across the United States.
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