Siemens Fluoroscopic X-Ray Systems Recalled for Radiation Malfunction
Siemens is recalling specific fluoroscopic x-ray systems due to a software defect that may 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 (radiation exposure) where the source text identifies a hazard to patients but does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 357 units of Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia fluoroscopic x-ray systems. The affected units are equipped with software version VC10 and were distributed nationwide in the United States and internationally to Canada.
The recall is issued because a potential malfunction may cause radiation to continue longer than required during use. This defect can result in overexposed images that are not of diagnostic quality, posing a hazard to patients.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software issue. The source text does not specify a particular action for individual patients, but the malfunction is identified as a hazard to patients using these systems.
The recalled product
- Product
- (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 357
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 (5)
- Model numbers: 10094200
- 10094910
- 10281013
- 10281163
- 10502200
Distribution
Distributed nationwide across the United States.
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