Artis Zee Angiographic x-ray systems.

This recall has been terminated (originally issued March 31, 2014).

Company: Siemens Medical Solutions Usa, Inc
Recall Initiated: February 7, 2014
Posted: March 31, 2014
Terminated: March 16, 2015
Recall Number: Z-1309-2014
Quantity: 9
Firm Location: Malvern, PA
Official Source: View on FDA website ↗

Reason for Recall

An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.

Distribution

MN, WI, PA, MI, AL, OH, NC, AR, and NJ.

AL AR MI MN NC NJ OH PA WI

Lot / Code Info

Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959.

Root Cause

Device Design

Action Taken

A recall notification letter dated February 7, 2014, was sent to End Users.