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FDA Device recall Z-0992-2013

Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiograph…

On 2013-04-03 the FDA classified a Class II recall of Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiograph… by Siemens Medical Solutions Usa, citing in the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego system with software rev….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0992-2013
ClassificationClass II
Statusterminated
Initiated2012-11-26
Published2013-04-03
Last updated2026-09-13 11:53 UTC
CompanySiemens Medical Solutions Usa
DistributionUS

Product

Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system

Reason

In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego system with software revision VC14, VC20 and VC21 in conjunction with a specific technical configuration which cannot be completely executed.

Identifiers

code_info
Model number 10280959 -- serial numbers 160395, 160484, 190348, 160502, 160351, 160463, 160823, 160406, 160347, 160506,…Model number 10280959 -- serial numbers 160395, 160484, 190348, 160502, 160351, 160463, 160823, 160406, 160347, 160506, 160142, 160801, 160486, 160431, 160100, 160814, 160391, 160008, 160411, 160438, 160450, 160149, 160830, 160483, 160813, 160460, 160485, 160443, 160122, 160401, 160494, 160507, 160007, 160001, 160825, 160508, 160482, 160505, 160322, 160323, 160382, 160421, 160129, 160357, 160498, 160413, 160414, 160373, 160509, 160817, 160101 and 160469.

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-0992-2013%22

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