PlainRecalls
FDA Devices Moderate Class II Terminated

AXIOM Vertix MD Trauma systems radiographic X-ray

Reported: April 23, 2014 Initiated: March 5, 2014 #Z-1460-2014

Product Description

AXIOM Vertix MD Trauma systems radiographic X-ray

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.

Details

Units Affected
2
Distribution
US Distribution including MO and OH.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
AXIOM Vertix MD Trauma systems radiographic X-ray. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 2.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 23, 2014. Severity: Moderate. Recall number: Z-1460-2014.