ACUSON Juniper Diagnostic Ultrasound System
Hazard
Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
What You Should Do
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
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
- Brand
- Siemens Medical Solutions USA, Inc.
- UPC
- 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;
Units Affected
15 systems