Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure Risk
Siemens is recalling 11 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.
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 that the defect 'can result in severe injuries to patients and operating personnel,' which aligns with the rubric criterion for 'significant injury' reports or risks, warranting a score of 4.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 11 units of the Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System (Model Number: 10848355). The recall also covers Artis Zee, Artis Q, Artis Pheno, or Artis Icono systems equipped with a DCS Extended or DCS Movable. The affected units were distributed nationwide.
The recall is due to a defect in the screwed connection joining the pivot bearing to the ceiling-mounted support. Individual screws in this connection have the potential to work loose or snap off. This failure can result in severe injuries to patients and operating personnel.
The specific serial numbers for the recalled units are 123049, 123216, 123046, 123236, 123211, 123202, 123043, 123219, 123240, 123230, and 123246. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this issue.
The recalled product
- Product
- Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 11
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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