ACUSON Juniper Diagnostic Ultrasound System
FDA Recall Z-2471-2021 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2021-07-12
Date Terminated2024-10-16
Product Quantity15 systems
Reason for Recall
Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
Firm Action
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]
Root Cause
Software change control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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