Siemens Artis Fluoroscopic X-ray Systems Recalled for Display Soldering Defect
Siemens is recalling 17 Artis fluoroscopic X-ray systems due to improper soldering in display modules that could cause video signal loss.
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 explicitly states the issue has not been observed in the field and only sporadic cases were seen in factory screening, fitting the criteria for a voluntary precautionary recall with no reported harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 17 Artis interventional fluoroscopic X-ray systems with large displays. The recall is due to improper soldering in a limited number of large display bypass module components from a specific production lot.
This defect could potentially cause a loss of video signal. The source text notes that this issue has not been observed in the field and only sporadic cases have been observed in factory screening.
The affected units were distributed to hospitals and facilities in Illinois, Wisconsin, Massachusetts, Florida, Alabama, Tennessee, North Dakota, Ohio, Texas, California, New Jersey, and Michigan. Affected model numbers include 10094135, 10094137, 10094141, 10848280, 10848281, 10848282, and 10848355. Affected serial numbers include 123026, 147909, 123031, 103030, 147912, 147910, 147921, 147919, 131005, 121096, 125004, 137551, 121088, 109104, 109105, 109107, and 121085.
The recalled product
- Product
- Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 17
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)
- Model numbers 10094135
- 10094137
- 10094141
- 10848280
- 10848281
- 10848282
- 10848355. Serial Numbers 123026
- 147909
- 123031
- 103030
- 147912
- 147910
- 147921
- 147919
- 131005
- 121096
- 125004
- 137551
- 121088
- 109104
Distribution
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