Siemens AXIOM Artis zeego x-ray system safety notice issued
Siemens issued a customer safety notice regarding system information overlays after brake functional checks on the AXIOM Artis zeego x-ray system.
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, but the source text does not report any hospitalizations, injuries, or deaths, and the issue is described as a system information overlay rather than a direct physical hazard.
Plain-English summary
Siemens Medical Solutions USA, Inc. issued a customer safety notice concerning the Siemens AXIOM Artis zeego x-ray, angiographic system. The notice addresses the overlay of system information that occurs after a functional check of the brakes on the Artis Zeego system.
The recall involves 132 units of the system, identified by model number 10280959. These units were distributed nationwide to locations in AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NY, OH, PA, PR, SD, TN, TX, UT, VA, WA, and WI.
The source text does not specify specific instructions for consumers or end-users, nor does it report any injuries or illnesses associated with this issue. The notice is classified as a Class II recall by the FDA.
The recalled product
- Product
- Siemens AXIOM Artis zeego x-ray, angiographic system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 132
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 number 10280959
Distribution
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