Agency classClass IIOur severity:Severe FDA (Devices)·Z-1897-2019·Announced 2019-07-10

Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure Risk

Siemens is recalling 29 Artis X-ray systems because ceiling mount 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/property-damage reports' or high-risk structural defects.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 29 units of the Siemens Artis zeego Interventional Fluoroscopic X-Ray System (Model Number: 10280959). The recall also covers Artis Zee, Artis Q, Artis Pheno, and 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 may work loose or snap off. This failure can result in severe injuries to patients and operating personnel.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. The specific serial numbers for the affected units are listed in the official recall documentation.

The recalled product

Product: Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Equipment
Hazard: structural-failure
falling-object
severe-injury
Affected units: 29

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 →

Same manufacturer · Siemens Medical Solutions USA, Inc

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Same hazard · structural failure