Siemens RAD Fluoro Uro System Recalled for Image Malfunction
Siemens is recalling 76 RAD Fluoro Uro Systems because a software malfunction can cause images to appear very dark, potentially leading to unnecessary repeat examinations.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software malfunction leading to unnecessary repeat examinations, which is a low-risk operational issue without reported injuries or serious harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 76 units of the RAD Fluoro Uro System, including the Ysio, Luminos dRF, and Uroskop Omnia models. The affected units are equipped with software version VB10G and have model numbers 10094910, 10281013, and 10281163. These systems are image-intensified fluoroscopic X-ray devices.
The recall is due to a potential malfunction in systems operating with software versions VD10A/G during a RAD examination. This malfunction can result in the image appearing very dark. If this occurs, it may prompt the medical provider to repeat the examination unnecessarily.
The affected units were distributed nationwide in the United States, specifically in the states of Ohio, New Jersey, Massachusetts, Colorado, New York, California, Maryland, Oregon, Kentucky, Pennsylvania, Illinois, Virginia, Texas, Minnesota, Kansas, Georgia, and Wyoming. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 76
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 (3)
- Model numbers 10094910
- 10281013
- and 10281163 with software version VB10G.
Distribution
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