Z-0458-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 21, 2018
- Initiation Date
- October 19, 2018
- Termination Date
- April 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