Siemens ARTIS Pheno X-Ray System Recalled for Temperature Control Defect
Siemens is recalling 429 ARTIS Pheno Interventional Fluoroscopic X-Ray Systems because a temperature control defect may cause the detector to cool below its designed operating range.
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. The hazard involves a functional defect (temperature control) that may cause the device to operate outside its designed range, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 429 units of the ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000. The recall is due to a defect in the temperature control unit that may be incorrectly configured.
This defect can cause the temperature of the detector to fall out of its designed working range, specifically by cooling down. This unintentional system behavior may occur while the unit is powered down for long periods, such as at night. The affected units were distributed nationwide in the United States.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the temperature control configuration issue.
The recalled product
- Product
- ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 429
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)
- 164013 164011
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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