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FDAFDA · Food and drugs·Recall number Z-1460-2014

AXIOM Vertix MD Trauma systems radiographic X-ray

Published April 23, 2014 · Recall initiated: March 5, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In rare cases, steel ropes inside the lift column of the system can be defective without triggering the safety lock, which can result in the U-arm dropping down unexpectedly during movement in vertical direction, potentially causing serious injury.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Siemens Medical Solutions USA, Inc
Distributor
US Distribution including MO and OH.
Lot
AXIOM Vertix MD Trauma systems (material no. 08908290) with serial numbers 1022 through 1058.
Risk classification
Class II
Area (FDA)
device
Country
United States

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