PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 30, 2014 Initiated: February 13, 2014 #Z-1505-2014

Product Description

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.

Reason for Recall

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

Details

Units Affected
12
Distribution
Distributed in the states of AK, PA, KY, OH, WI, MI, FL, and NY.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 12.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 30, 2014. Severity: Moderate. Recall number: Z-1505-2014.

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