Agency classClass IIOur severity:Severe FDA (Devices)·Z-1902-2019·Announced 2019-07-10

Siemens Artis X-Ray Systems Recalled for Potential Screw Failure

Siemens is recalling eight Artis X-ray systems because screws on the ceiling-mounted support 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 risk of severe harm, warranting a score of 4.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling eight Siemens Artis Q.zen floor Interventional Fluoroscopic X-Ray Systems (Model Number: 10848353). The recall involves specific serial numbers: 105018, 105016, 105032, 105124, 105119, 105123, 105121, and 105122. The 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 could result in severe injuries to patients and operating personnel.

This recall affects facilities using Siemens Artis Zee, Artis Q, Artis Pheno, or Artis Icono systems equipped with a DCS Extended or DCS Movable. Users should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect.

The recalled product

Product: Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Equipment
Hazard: structural-failure
severe-injury
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: 105018 105016 105032 105124 105119 105123 105121 105122

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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