Home / Recalls / Siemens Medical Solutions USA, Inc / Z-0458-2019

Z-0458-2019 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-0458-2019 was initiated by Siemens Medical Solutions USA, Inc on Oct 19, 2018 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated Apr 27, 2020). Affected quantity: 54 units.

Recall Details

Product Type: Devices
Report Date: Nov 21, 2018
Initiation Date: Oct 19, 2018
Termination Date: Apr 27, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 54 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

US Nationwide Distribution

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0458-2019
openFDA file date: Oct 21, 2026
Loaded by RegDataLab: Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.