—#168866

Product

ARTIS Q biplane with Material 10848282- - 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: 121336 121368 121208 121371 121374 121209 121325 121357 121378 121369 121364 121314 121351 121354 121340 121365 121324 121216 121333 121381 121352 121355 121210 121215 121379 121366 121323 121370 121384 121332 121344 121309 121305 121342 121301 121315 121372 121321 121383 121312 121359 121322 121356 121319 121211 121375 121377 121361 121339 121310 121362 121316 121212 121313

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 #168866. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.