FDA Device recall Z-0486-2015

The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide s…

FDA Device
Class II
terminated
Published 2014-12-10

On 2014-12-10 the FDA classified a Class II recall of The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide s… by Siemens Medical Solutions Usa, citing there is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the "Bloc….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0486-2015
Classification	Class II
Status	terminated
Initiated	2013-09-11
Published	2014-12-10
Last updated	2026-09-13 11:53 UTC
Company	Siemens Medical Solutions Usa
Distribution	US

Product

The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

Reason

There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the "Block Radiation" key on the touch screen control. If this behavior occurs, the system image generation function is not available for patient examinations without switching the system off and back on again manually. This

Identifiers

code_info	model numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 153229 153131… model numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 153229 153131 146669 146877 146996 157435 146663 147100 147233 147049 136077 135746 153172 135229 160313 146174 153315 153318 153317 146121 146710 146945 153992 147084 147189 147190 153335 153695 135120 135322 146679 153102 153101 146232 157660 153727 146728 146408 146409 157458 153216 146335 153779 146659 146993 153280 153648 153674 160395 153166 146898 146965 160484 135757 136513 153700 154096 135000 136562 146221 147273 157698 146871 146814 146952 147239 147030 135914 153834 146988 160348 157532 160502 146899 153194 153169 135102 146643 146650 136085 146980 146361 146365 146366 146369 146912 147036 135927 153110 146116 146164 146168 157657 160392 153890 157136 154157 153199 135209 140106 147371 153887 160115 146156 146342 146343 135986 153269 154074 157690 135935 135953

code_info

model numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 153229 153131…

model numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 153229 153131 146669 146877 146996 157435 146663 147100 147233 147049 136077 135746 153172 135229 160313 146174 153315 153318 153317 146121 146710 146945 153992 147084 147189 147190 153335 153695 135120 135322 146679 153102 153101 146232 157660 153727 146728 146408 146409 157458 153216 146335 153779 146659 146993 153280 153648 153674 160395 153166 146898 146965 160484 135757 136513 153700 154096 135000 136562 146221 147273 157698 146871 146814 146952 147239 147030 135914 153834 146988 160348 157532 160502 146899 153194 153169 135102 146643 146650 136085 146980 146361 146365 146366 146369 146912 147036 135927 153110 146116 146164 146168 157657 160392 153890 157136 154157 153199 135209 140106 147371 153887 160115 146156 146342 146343 135986 153269 154074 157690 135935 135953

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0486-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.