The Recall Desk
SevereFDA (Devices)·Z-1899-2019·Announced 2019-07-10

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

Siemens is recalling 131 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.

What this means for you

Illness, injury, or structural failure has been reported. 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 131 units of the Siemens Artis Q ceiling-mounted Interventional Fluoroscopic X-Ray System, Model Number 10848281. The recall also covers Artis Zee, Artis Pheno, and Artis Icono systems equipped with a DCS Extended or DCS Movable. The affected units were distributed nationwide.

The recall was issued because the screws in the connection joining the pivot bearing to the ceiling-mounted support may work loose or snap off. This defect 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 responsible for addressing the defect.

The recalled product

Product
Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281
Affected units
131

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

See all →