Recall Z-1460-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1460-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-05

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-03-05, terminated 2015-03-16. It names one FDA 510(k) clearance: K971452. Product: AXIOM Vertix MD Trauma systems radiographic X-ray. 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Terminated: 2015-03-16
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K971452 — MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLESiemens Medical Solutions USA, Inc.·cleared 1997-05-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.