Siemens Medical Solutions USA, Inc. ACUSON Juniper Diagnostic Ultrasound System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACUSON Juniper Diagnostic Ultrasound System
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
O.U.S. Serial Numbers: 550975, 552770, 553629, 553951, 555060, 555601, 555602, 555604, 555605, 555610, 555611, 555612, 555613, 555626, O.U.S. Inactive Serial Numbers: 555603, 555607
Products Sold
Model Number: 11335791 UDI: (01)04056869152059 (21)123456 (240)11335791 (422)410 Firmware version 3.8 for rev. 7 U.S. Serial Number: 555606; O.U.S. Serial Numbers: 550975; 552770; 553629; 553951; 555060; 555601; 555602; 555604; 555605; 555610; 555611; 555612; 555613; 555626; O.U.S. Inactive Serial Numbers: 555603; 555607;
Siemens Medical Solutions USA, Inc. is recalling ACUSON Juniper Diagnostic Ultrasound System due to Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
Recommended Action
Per FDA guidance
On 07/12/2021, the firm sent a "MEDICAL DEVICE SAFETY CORRECTION" Notification via email to customers informing them that there are intermittent failures of the power supply in the ultrasound system which may render the system inoperable. When an ultrasound system experiences this failure, cycling the power does not recover system functionality. Potential health risks include, lack of ultrasound guidance during interventional procedures (e.g., biopsy, guidance during surgery, patient under sedation) that rely on real-time ultrasound imaging to guide or complete the procedure. Customer will be contacted by a Customer Service Engineer to schedule a visit to their facility to update the system. Customers are asked to ensure that all users are aware of this issue and correction within their organization and others who may need to be inform of this situation. For further questions, contact Siemens Healthineers USD Complaints at usd-complaint.team@siemens-healthineers.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026