Siemens Medical Solutions Recalls Artis Q and Q.Zen Systems
Siemens Medical Solutions is recalling Artis Q and Q.Zen systems due to a potential for liquid entry.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling Artis Q and Q.Zen medical devices, including model numbers 10848280, 10848281, 10848282, 10848353, and 10848355. The recall is being conducted because of a potential for liquid entry into the devices.
The affected units were distributed nationwide in the United States. The source text does not specify the number of units recalled or the specific dates of distribution.
Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
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)
- 10094135
- 10094137
- 10094141
- 10094142
- 10094143
- 10280959
- 10848280
- 10848281
- 10848282
- 10848353
- 10848354
- 10848355
- 5904433
- 5904441
- 5904649
- 5904656
- 5917054
- 7007755
- 7008605
- 7412807
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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