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Recall Observatory FDA recall evidence

Device product

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 including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.

Z-1505-2014

February 13, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 67568
Status
Terminated
Classification
Class II
Quantity
12
Official record key
device-enforcement:Z-1505-2014

Official wording

Reason: 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

Code information: model nos. 10746665, 10746666, 10847610, 10746700

Distribution pattern: Distributed in the states of AK, PA, KY, OH, WI, MI, FL, and NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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