Recall – Angiography system error can delay procedure

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 12/1/2021
Class II

PRODUCT

Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135

Recall Number: Z-0296-2022

Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137

Recall Number: Z-0297-2022

Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139

Recall Number: Z-0298-2022

Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139

Recall Number: Z-0298-2022

Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141

Recall Number: Z-0299-2022

Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280

Recall Number: Z-0300-2022

Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281

Recall Number: Z-0301-2022

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

Recall Number: Z-0302-2022

Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353

Recall Number: Z-0303-2022

Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354

Recall Number: Z-0304-2022

Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355

Recall Number: Z-0305-2022

REASON

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.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc on 10/20/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION

U.S. Nationwide

Cybersecurity Review

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