—#168867

Product

ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123529
Affected lot / code info: Serial Numbers: Serial 123202 123211 123208 123209 123206 123207 123219 123205 123201 123055 123056 123216 123200 123212

Why it was recalled

Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support

Root cause (FDA determination)

Device Design

Action the firm took

Siemens issued on 10/19/18 an Urgent Medial Devoce Correction notification to via AX033/18/S advising users of the problem, health risk, steps to be taken. Siemens has initiated screw connection exchange of the ceiling bearing via Update Instruction AXOSS/17 /S.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2018-10-19
Terminated: 2020-04-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168867. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.