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Recall Observatory FDA recall evidence

Device product

AXIOM Vertix MD Trauma systems radiographic X-ray

Z-1460-2014

March 05, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 67780
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-1460-2014

Official wording

Reason: 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.

Code information: AXIOM Vertix MD Trauma systems (material no. 08908290) with serial numbers 1022 through 1058.

Distribution pattern: US Distribution including MO and OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.