Recalls / —

—#188585

Product

ACUSON Juniper Diagnostic Ultrasound System

FDA product code

IYN — System, Imaging, Pulsed Doppler, Ultrasonic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K201130

Affected lot / code info

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;

Why it was recalled

Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.

Root cause (FDA determination)

Software change control

Action the firm took

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

Recalling firm

Firm

Siemens Medical Solutions USA, Inc.

Address

22010 SE 51st St, Issaquah, Washington 98029-7298

Distribution

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.

Timeline

Recall initiated

2021-07-12

Terminated

2024-10-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #188585. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.