Reported Apr 23, 2014 · Terminated

AXIOM Vertix MD Trauma systems radiographic X-ray

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 51 Valley Stream Pkwy · Malvern, PA · 19355

Is this the product you have?

  • AXIOM Vertix MD Trauma systems radiographic X-ray
Lot codes and dates
  • AXIOM Vertix MD Trauma systems (material no. 08908290) with serial numbers 1022 through 1058.
Amount recalled
2

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 16, 2015 · Data as of Sep 19, 4:49 PM UTC

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