Siemens Fluoroscopic X-Ray Systems Recalled for Potential Screw Failure
Siemens is recalling eight Artis fluoroscopic X-ray systems because screws on the ceiling-mounted support may loosen or snap, posing a risk of severe injury.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the defect 'can result in severe injuries to patients and operating personnel,' which aligns with the rubric criterion for 'significant injury' reports or risk of severe harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling eight Siemens Artis pheno Interventional Fluoroscopic X-Ray Systems (Model Number: 10849000). The recall covers systems equipped with a DCS Extended or DCS Movable. The affected units were distributed nationwide.
The recall is due to a potential defect where individual screws in the connection joining the pivot bearing to the ceiling-mounted support may work loose or snap off. This failure could result in severe injuries to patients and operating personnel.
The specific serial numbers for the affected units are 164021, 164053, 164055, 164054, 164088, 164140, 164113, and 164069. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this issue.
The recalled product
- Product
- Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 8
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)
- Serial Numbers: 164021 164053 164055 164054 164088 164140 164113 164069
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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