MULTIX FUSION — Class II medical device recall Z-1505-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-04-30, distributed in AK, FL, KY, MI, NY, OH, PA, WI. It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose. Ac
| Recall number | Z-1505-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2014-02-13 |
| Classified | 2014-04-24 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2015-03-16 |
| Distributed | AK, FL, KY, MI, NY, OH, PA, WI |
| Quantity | 12 |
| Model numbers | 10746665, 10746666, 10746700, 10847610 |
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.
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.