FDA Device recall Z-0196-2024

Updated 12/4/23 (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System

FDA Device
Class II
ongoing
Published 2023-11-08

On 2023-11-08 the FDA classified a Class II recall of ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System by Siemens Medical Solutions Usa, citing software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patie….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0196-2024
Classification	Class II
Status	ongoing
Initiated	2023-09-12
Published	2023-11-08
Last updated	2026-09-13 11:56 UTC
Company	Siemens Medical Solutions Usa
Distribution	US

Product

***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of the anatomical structures of patients during clinical applications Material Number: 10308194

Reason

Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure

Identifiers

code_info	*Updated 12/4/23* (1) UDI-DI: 04056869246628 S/N: 80006 80009 80010 80014 80017 80018 80019 80020 80021 80022 800… *Updated 12/4/23* (1) UDI-DI: 04056869246628 S/N: 80006 80009 80010 80014 80017 80018 80019 80020 80021 80022 80023 80025 80026 80028 80031 80032 80033 80048 80051 80052 80053 80055 80059 80060 80063 80064 80065 80067 80068 80069 80071 80072 80073 80074 80075 80080 80081 82010 82011 82012 82013 82028 82031 82036 82037 82038 82039 82040 82043 82044 82045 82046 82061 82075 82076 82079 82080 82089 82092 82095 82096 82097 82112 82123 82124 82131 82132 82139 82144 82157 82159 82160 82161 82162 82163 82172 82176 82177 82178 82182 82183 82193 82194 82196 82198 82199 82200 82203 82205 82206 82207 82215 82223 82226 82227 82229 82236 82239 83003 83004 83005 83007 83008 83011 83012 83013 83023 83027 83029 83030 83034 83035 83038 83039 83040 83041 83048 83052 83053 83060 83063 83064 83070 83074 83086 83093 83094 83100 83102 83104 83108 83110 83112 83114 83115 83116 83117 83126 83128 83134 83138 83140 83141 83143 83144 83154 83155 83161 83194 83196 83220 83228 83229 83233 83245 83246 83247 83

code_info

***Updated 12/4/23*** (1) UDI-DI: 04056869246628 S/N: 80006 80009 80010 80014 80017 80018 80019 80020 80021 80022 800…

***Updated 12/4/23*** (1) UDI-DI: 04056869246628 S/N: 80006 80009 80010 80014 80017 80018 80019 80020 80021 80022 80023 80025 80026 80028 80031 80032 80033 80048 80051 80052 80053 80055 80059 80060 80063 80064 80065 80067 80068 80069 80071 80072 80073 80074 80075 80080 80081 82010 82011 82012 82013 82028 82031 82036 82037 82038 82039 82040 82043 82044 82045 82046 82061 82075 82076 82079 82080 82089 82092 82095 82096 82097 82112 82123 82124 82131 82132 82139 82144 82157 82159 82160 82161 82162 82163 82172 82176 82177 82178 82182 82183 82193 82194 82196 82198 82199 82200 82203 82205 82206 82207 82215 82223 82226 82227 82229 82236 82239 83003 83004 83005 83007 83008 83011 83012 83013 83023 83027 83029 83030 83034 83035 83038 83039 83040 83041 83048 83052 83053 83060 83063 83064 83070 83074 83086 83093 83094 83100 83102 83104 83108 83110 83112 83114 83115 83116 83117 83126 83128 83134 83138 83140 83141 83143 83144 83154 83155 83161 83194 83196 83220 83228 83229 83233 83245 83246 83247 83

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0196-2024%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.