Z-1460-2014Class II

AXIOM Vertix MD Trauma systems radiographic X-ray

Name: Z-1460-2014 AXIOM Vertix MD Trauma systems radiographic X-ray
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-03-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-03-05 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Vertix MD Trauma systems radiographic X-ray on 2014-03-05. FDA classified it as Class II and gives the reason as "There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In rare cases, steel ropes inside the lift column of the system can be defective without triggering the safety...". 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-1460-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Posted: 2014-04-16
Terminated: 2015-03-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Vertix MD Trauma systems radiographic X-ray
Product code: IZZ Table, Radiographic, Non-Tilting, Powered
Reason for recall: There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In rare cases, steel ropes inside the lift column of the system can be defective without triggering the safety lock, which can result in the U-arm dropping down unexpectedly during movement in vertical direction, potentially causing serious injury.
Root cause tag: design
FDA root cause: Component design/selection
Action: Siemens sent a Safety Advisory Notice dated March 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised as a first check it is strongly recommended for the users to check whether metallic dust or rubbed off parts of metal are visible underneath the lifting column or around the system. If this is the case, it is strongly recommended to immediately stop using the Vertix MD Trauma system and call the local Siemens service. To avoid any risk until the implementation of the modification mentioned below, it is furthermore strongly recommended to perform up/down movements of the lifting column not directly above the patient, but complete the vertical movement beside the patient and then move the system horizontally above the patient. We appreciate your understanding and cooperation with this Safety Advisory Notice and ask you to immediately instruct your personnel accordingly. Please ensure that this Safety Advisory Notice is placed in the system's instructions for use until the update has been installed. If you have sold or otherwise disposed of this equipment and it is no under your control, we kindly ask that you forward this Safety Advisory Notice to the new user of the equipment. Please also inform us about the new owner of the equipment. We apologize for any inconvenience this may cause. Further questions please call (610) 219-6300.
Quantity in commerce: 2
Distribution: US Distribution including MO and OH.
Product codes and lots: AXIOM Vertix MD Trauma systems (material no. 08908290) with serial numbers 1022 through 1058.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1460-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1460-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-16

Product code IZZ

K971452Class IIMultix Top/pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. / cleared 1997-05-14

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)