Class 2 Device Recall ACUSON Juniper Diagnostic Ultrasound System

• Date Initiated by Firm: January 19, 2022
• Create Date: March 11, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0748-2022
• Recall Event ID: 89499
• 510(K)Number: K201130
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE ; ; Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.
• Code Information: Serial Numbers 550010 550011 550015 550016 550018 550019 550020 550021 550023 550024 550025 550026 550027 550028 550029 550030 550031 550032 550033 550034 550035 550036 550037 550038 550039 550040 550041 550042 550043 550044 550046 550047 550048 550049 550050 550051 550052 550055 550056 550057 550058 550059 550062 550063 550064 550065 550066 550067 550068 550069 550070 550071 550072 550073 550074 550075 550077 550079 550082 550083 550084 550085 550086 550087 550088 550089 550092 550093 550094 550095 550097 550099 550103 550109 550110 550111 550112 550114 550116 550117 550118 550119 550120 550122 550123 550124 550125 550126 550127 550129 550130 550131 550132 550133 550134 550135 550136 550137 550139 550140 550141 550142 550143 550144 550145 550146 550148 550149 550150 550152 550153 550154 550155 550157 550158 550159 550160 550161 550163 550164 550165 550166 550167 550168 550169 550170 550171 550172 550173 550174 550175 550177 550180 550181 550182 550184 550185 550186 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• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 22010 SE 51st St; Issaquah WA 98029-7298
• For Additional Information Contact: 425-392-9180
• Manufacturer Reason for Recall: The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.
• FDA Determined Cause: Software design
• Action: The firm, Siemens Healthineers, sent "URGENT MEDICAL DEVICE SAFETY CORRECTION" Letters Juniper 1.0 (VA10D/VA10E/VA10F) to affected customers via Siemens update program US026/21/S informing them of the issue and advising them the firm will correct this issue with a free-of-charge software update to their ACUSON Juniper ultrasound system. The customers were instructed to do the following: Check the available storage on the ultrasound system prior to starting a study where clips are vital to the documentation, such as stress echo. If available, use a different ultrasound system capable of performing a stress echo exam until the problem is resolved. If another ultrasound system is not available, consider using other imaging modalities to achieve the diagnostic outcome. In the event that a defect is encountered, a reinstallation of the system software can resolve this problem until the available storage on the ultrasound system is again exceeded. The customers' respective customer service engineer will contact them to schedule a facility visit to update the system or inform them of a remote update. If you have further questions regarding this safety correction, please send all inquiries to: Siemens Healthineers USD Complaints usd-complaint.team@siemens-healthineers.com.
• Quantity in Commerce: 2846
• Distribution: Worldwide distribution: US (nationwide) and countries of: Algeria, Andorra, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kosovo, Kuwait, Latvia, Liechtenstein, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay, Vietnam, and Zimbabwe.
• 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 = IYN and Original Applicant = Siemens Medical Solutions USA, Inc.