Class 2 Device Recall Cios Flow, Cios Spin

• Date Initiated by Firm: September 12, 2023
• Date Posted: October 27, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0196-2024
• Recall Event ID: 93127
• 510(K)Number: K203504 K210054
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• 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
• Code Information: ***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 83249 83273 83281 83283 83285 83303 83307 83311 83356 83357 83373 83374 83376 83412 83425 83441 83449 83454 83456 83458 83465 83473 83476 83490 83491 83493 83497 83514 83515 2) UDI-DI: 04056869153506 Serial: 50030 50032 50033 50048 50050 50051 50072 50073 50075 50079 50081 50088 50094 50096 50098 50101 50107 50109 50111 50120 50122 50123 50124 50127 50129 50130 50131 50132 50135 50153 50155 50166 50171 50184 50185 50192 50198 50199 50200 50201 50209 50210 50211 50213 50214 50215 50216 50219 50222 50276 50282 50302 50311 50315 50426 50427 50429 50431 50444 52008 52011 52018 52019 52022 52023 52024 52026 52027 52028 52029 52030 52034 52036 52037 52050 52070 52075 52078 52082 52088 52091 52093 52104 52108 52110 52111 52113 52116 52117 52121 52122 52124 52127 52130 52132 52137 52139 52140 52147 53006 53007 53008 53010 53011 53012 53014 53018 53024 53027 53030 53033 53035 53038 53039 53040 53042 53045 53047 53048 53049 53050 53053 53056 53057 53065 53067 53071 53072 53080 53087 53089 53095 53098 53099 53100 53102 53104 53105 53107 53108 53113 53117 53136 53153 53155 53156 53157 53158 53161 53163 53166 53168 53170 53172 53173 53174 53175 53178 53179 53181 53183 53185 53191 53194 53195 53198 53199 53200 53201 53202 53203 53205 53206 53207 53209 53210 53213 53214 53215 53218 53224
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Meredith Adams; 610-219-4834
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Software design
• Action: Siemens Medical Solutions USA issued Urgent Medical Device Correction Letter (AX035/23/S).Letter states reason for recall, health risk and action to take. Siemens will correct the software error via Update Instruction AX036/23/S. With software version VA30K, the user interface of Cios VA30 systems will be changed to consider the current standards DIN 6862-3 and IEC 60601-2-54. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification. If you have received this notification by email via Adobe GigaSign, kindly sign with your digital signature to acknowledge that you have read and understand the content provided. If you have received this customer notification by delivery by the US Postal Service or by FedEx, please send an email to recallsandrefusals.team@siemens-healthineers.com acknowledging that you have read and understand the content provided. Please ensure that all users of the affected products within your organization and others who may need to be informed will receive the relevant safety information provided within this notice and will comply with the recommendations therein.
• Quantity in Commerce: ***Updated 12/4/23*** 186 units Cios Flow, 181 units Cios Spin
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB; 510(K)s with Product Code = OWB