—#125716

Product

Artis Zee Angiographic x-ray systems.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K073290
Affected lot / code info: Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

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

Timeline

Recall initiated: 2014-02-07
Posted by FDA: 2014-03-31
Terminated: 2015-03-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125716. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.