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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Product Detail

Product Description AXIOM Vertix MD Trauma systems radiographic X-ray
Recall Number Z-1460-2014
Classification Class II
Code Info AXIOM Vertix MD Trauma systems (material no. 08908290) with serial numbers 1022 through 1058.
Product Distributed Qty 2
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.

Event Detail

Event Id 67780
Product Type Devices
Status Ongoing
Recalling Firm Siemens Medical Solutions USA, Inc
City Malvern
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution including MO and OH.