Siemens Artis Angiographic X-Ray Systems Recalled for Image Registration Issues
Siemens is recalling 81 Artis angiographic x-ray systems because a software issue may cause imprecise image registration during specific procedures.
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 high-risk medical device where a software defect could lead to imprecise image registration, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 81 Artis angiographic x-ray systems equipped with specific software versions and a DSA license. The affected units are identified by model numbers 10094135, 10094137, 10094139, 10094141, and 10280959.
The recall is due to a potential software issue where executing a specific roadmap organ program in DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image on the live monitor. This issue occurs under certain preconditions.
The affected systems were distributed nationwide, including in Alabama, California, Colorado, Florida, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin, and Puerto Rico. Healthcare facilities should contact Siemens for instructions on how to address the software issue.
The recalled product
- Product
- Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 81
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 (4)
- Model numbers 10094135
- 10094137
- 10094139
- 10094141 and 10280959.
Distribution
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