The Recall Desk
SevereFDA (Devices)·Z-1895-2019·Announced 2019-07-10

Siemens Artis zee Ceiling X-Ray System Recall for Loose Screws

Siemens is recalling 276 Artis zee ceiling-mounted X-ray systems because screws joining the pivot bearing to the ceiling support may work loose or snap off, posing a risk of severe injury.

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 risk of severe harm, warranting a score of 4 (Severe).

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 276 units of the Siemens Artis zee ceiling-mounted Interventional Fluoroscopic X-Ray System (Model Number: 10094137). The recall also applies to Artis Q, Artis Pheno, or Artis Icono systems equipped with a DCS Extended or DCS Movable.

The recall was issued because individual 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. The affected units were distributed nationwide.

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 addressing the defect.

The recalled product

Product
Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137
Affected units
276

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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