Siemens Fluoroscopic X-Ray Systems Recalled for Potential Radiation Malfunction
Siemens is recalling 23 fluoroscopic X-ray systems due to a potential malfunction that may cause radiation to continue longer than expected, resulting in unnecessary dose.
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 criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 23 Siemens RAD Fluoro Uro Systems, including Luminos dRF, Ysio, and Uroskop Omnia models, equipped with software versions VB10D, VB10F, VB10C, and VB10E. The recall is due to a potential malfunction discovered through product monitoring.
During a RAD examination, the malfunction may cause radiation to continue longer than expected, which may result in an unnecessary dose being applied during an acquisition. Additionally, the source text notes that it is not possible for the user to stop the radiation manually in this scenario.
The affected units were distributed nationwide. Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address this issue.
The recalled product
- Product
- Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 23
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 (20)
- Material 10094910
- with serial numbers 1036
- 1045
- 1025
- 1040
- 1041
- 1032
- 1047 and 1035
- Material 10281013
- with serial numbers 21221
- 21223
- 21213
- 21089
- 21098
- 21163
- 21171
- 21194
- 21212
- 21186
- 21188
Distribution
Distributed nationwide across the United States.
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