—#126309

Product

AXIOM Vertix MD Trauma systems radiographic X-ray

FDA product code: IZZ — Table, Radiographic, Non-Tilting, Powered
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K971452
Affected lot / code info: AXIOM Vertix MD Trauma systems (material no. 08908290) with serial numbers 1022 through 1058.

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: US Distribution including MO and OH.

Timeline

Recall initiated: 2014-03-05
Posted by FDA: 2014-04-16
Terminated: 2015-03-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126309. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.