Recall Z-1505-2014 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
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.
| Date | Apr 24, 2014 (initiated Feb 13, 2014) |
| Status | Terminated |
| 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 |
| Root cause | Process change control |
| Action | Affected customers were initially notified with a recall letter on/about 2/12/14 and were sent Update Instructions to affected customers. |
| Quantity | 12 |
| Distribution | Distributed in the states of AK, PA, KY, OH, WI, MI, FL, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121513 | MULTIX FUSION Siemens Medical Solution, Aug 10, 2012 |