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
Product summary
- 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
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