Siemens Artis X-Ray Systems Recalled for Potential Ceiling Mount Failure
Siemens is recalling 73 Artis X-ray systems because ceiling-mounted support screws 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 that 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 significant injury, warranting a score of 4 (Severe).
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 73 units of the Siemens Artis Q biplane Interventional Fluoroscopic X-Ray System (Model Number 10848282). The recall also covers Artis Zee, Artis Pheno, and Artis Icono systems equipped with a DCS Extended or DCS Movable. These devices were distributed nationwide.
The recall is due to a defect where individual screws in the connection joining the pivot bearing to the ceiling-mounted support may work loose or snap off. This failure can result in severe injuries to patients and operating personnel.
Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Siemens is the recalling firm and is responsible for managing the corrective actions for these devices.
The recalled product
- Product
- Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 73
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.
See all 12 products in this recall →Related recalls
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