Reported Apr 30, 2014 · Terminated

MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices.…

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?

  • MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic
  • exposures of the whole body includingskull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients
Lot codes and dates
    • model nos. 10746665
    • 10746666
    • 10847610
    • 10746700
Amount recalled
12

Where it was sold

Why it was recalled

It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose. According to the Installation Instructions the corrugated hose holder shall be afixed with transversal carriage, with Loctite 243 and Torque 10nm during system installation. Siemens initiated the update instruction to verify and secure the hose holder with Loctite 243. A PCB D802 Rev. 00 b

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, 5:29 PM UTC

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