Z-0297-2019Class II

Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube...

Name: Z-0297-2019 Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube...
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-08-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-08-03 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059)... on 2018-08-03. FDA classified it as Class II and gives the reason as "Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0297-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-03
Posted: 2018-10-30
Terminated: 2019-11-26
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Wireless (model number 10893300) with Tube stand 3D V (model number 7042042)
Product code: KPR System, X-Ray, Stationary
Reason for recall: Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Healthineers issued Urgent Medical Device Correction notice dated August 3, 2018, informing potentially affected users via Safety Advisory Notice XP029/18/S to advise of the problem, risk to health, action to be taken (it is strongly recommended not to perform up/down movements of the lifting column directly above the patient. Instead, the vertical movement should be completed beside the patient and then the system should be moved horizontally to the patient). The service organization will contact to arrange a date to perform this corrective action with Update Instruction XP031/18/S. Contact service organization for an earlier appointment at 1-800-888-7436. Siemens Healthineers is preparing a corrective action that will resolve this potential issue. The corrective action will be distributed via an Update Instruction XP031/18/S.
Quantity in commerce: 35 units
Distribution: US nationwide distribution
Product codes and lots: Serial Numbers: 40279 10037 1176 40026 1220 40106 40208 40209 40109 40114 40140 40104 40126 40144 10040 10041 40027 40118 40105 40128 40200 40146 10039 40102 40101 40022 40125 40142 40127 40117 40206 1192 1185 40116 40119

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0297-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0297-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)