FDA Device recall Z-0748-2022
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the f…
- FDA Device
- Class II
- ongoing
- Published 2022-03-23
On 2022-03-23 the FDA classified a Class II recall of Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the f… by Siemens Medical Solutions Usa, citing 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 una….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0748-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-19 |
| Published | 2022-03-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Serial Numbers 550010 550011 550015 550016 550018 550019 550020 550021 550023 550024 550025 550026 550027 550028 550029…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 550188 550190 55019 |
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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-0748-2022%22
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