FDA Device recall Z-1505-2014
MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices
- FDA Device
- Class II
- terminated
- Published 2014-04-30
On 2014-04-30 the FDA classified a Class II recall of MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices by Siemens Medical Solutions Usa, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1505-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-13 |
| Published | 2014-04-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | AK, FL, KY, MI, NY, OH, PA, WI |
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
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
Identifiers
| code_info | model nos. 10746665, 10746666, 10847610, 10746700 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1505-2014%22
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