—#124865

Product

Siemens Artis zee Ceiling Systems. Angiographic x-ray system.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K073290
Affected lot / code info: Artis zee Ceiling systems serial numbers from 146352 to 147617

Why it was recalled

During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.

Root cause (FDA determination)

Device Design

Action the firm took

In December 2013, a recall notification letter was sent to Users.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2013-12-16
Posted by FDA: 2014-02-24
Terminated: 2015-03-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124865. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.