PlainRecalls
FDA Devices Moderate Class II Terminated

Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282

Reported: December 1, 2021 Initiated: October 20, 2021 #Z-0302-2022

Product Description

Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282

Reason for Recall

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

Details

Units Affected
15 units
Distribution
US Nationwide Distribution
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 15 units.
Why was this product recalled?
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Which agency issued this recall?
This recall was issued by the FDA Devices on December 1, 2021. Severity: Moderate. Recall number: Z-0302-2022.