Siemens ARTIS Q x-ray systems recalled for potential high-voltage generator failure
Siemens is recalling 264 ARTIS Q interventional fluoroscopic x-ray systems because a component in the A100G generator can age and fail.
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 is classified as FDA Class II and involves a potential mechanical failure of a high-voltage generator module. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 264 units of the ARTIS Q Interventional Fluoroscopic x-ray system. The recall affects 112 units distributed in the United States and 152 units distributed worldwide. The affected systems are identified by specific model and serial numbers listed in the agency's recall record.
The recall is due to a component in the A100G high-voltage generator that can be affected by aging. This aging could result in the potential failure of a module within the high-voltage generator. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the potential generator failure. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ARTIS Q, Interventional Fluroscopic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
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 (6)
- Model # 10848280
- 10848281
- 10848282
- 10848283
- 10848353
- 10848354
Distribution
Distribution scope not specified by the agency.
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