ACUSON Juniper Diagnostic Ultrasound System recallZ-2471-2021 · Siemens Medical Solutions USA, Inc. · initiated Jul 12, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
FDA root cause category: Software change control
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-2471-2021
- Status
- Terminated
- Initiated by the company
- Jul 12, 2021
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 15 systems
- Product code
- IYN
- FDA submissions
- K201130
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the Puerto Rico and the countries of Bosnia Herzegovina, Canada, Colombia, Germany, Greece, Italy, North Macedonia, Poland, and Slovenia.
Product description
ACUSON Juniper Diagnostic Ultrasound System
Code information (models, lots, serial numbers)
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;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ACUSON Juniper Diagnostic Ultrasound System 11335791Siemens Medical Solutions USA, Inc. · Transducer, ultrasonic, diagnostic3 recalls2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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