Z-1505-2014Class II

MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical...

Name: Z-1505-2014 MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-02-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-02-13 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic... on 2014-02-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1505-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-13
Posted: 2014-04-24
Terminated: 2015-03-16
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: KPR System, X-Ray, Stationary
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
FDA 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 in commerce: 12
Distribution: Distributed in the states of AK, PA, KY, OH, WI, MI, FL, and NY.
Product codes and lots: model nos. 10746665, 10746666, 10847610, 10746700

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1505-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1505-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-24

Product code KPR

K121513Class IIMultix FusionSiemens Medical Solution / cleared 2012-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)