FDAClass IIApril 30, 2014

MULTIX FUSION. The Multix Fusion system is a recall

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

Why was MULTIX FUSION. The Multix Fusion system is a 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

model nos. 10746665, 10746666, 10847610, 10746700

Product
MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
12
Distribution
Distributed in the states of AK, PA, KY, OH, WI, MI, FL, and NY.
Recall date
April 30, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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