Z-0013-2017Class II

Multix Fusion Stationary X-Ray System

Name: Z-0013-2017 Multix Fusion Stationary X-Ray System
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-08-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-08-01 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices... on 2016-08-01. FDA classified it as Class II and gives the reason as "Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0013-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-01
Posted: 2016-10-04
Terminated: 2016-12-13
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Multix Fusion Stationary X-Ray System Product Usage: 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. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens sent a Customer Safety Advisory Notice letter dated August 4, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to discontinue use of the tables until one of their service technicians can inspect the affected part of each table.
Quantity in commerce: 37 Systems
Distribution: US Nationwide Distribution
Product codes and lots: Model Number: 10762470, 10893300, 10746665 Serial Numbers: 24644,24613,24615,40328,24611,24612,24614,40326,40322,40316,24599,24600,40404,24634,2464124590,40402,1314,40312,24591,24592,40327,40323,24656,24659,40335,1315,40332,40403,24605,40325,40313,24645,24610,24580,24648,24581

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0013-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0013-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-03
Z-0014-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-03
Z-0015-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-03

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)