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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON Juniper ultrasound imaging system

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  Class 2 Device Recall ACUSON Juniper ultrasound imaging system see related information
Date Initiated by Firm July 12, 2021
Create Date September 14, 2021
Recall Status1 Open3, Classified
Recall Number Z-2471-2021
Recall Event ID 88405
510(K)Number K201130  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product ACUSON Juniper Diagnostic Ultrasound System
Code Information 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;
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
22010 SE 51st St
Issaquah WA 98029-7298
For Additional Information Contact Mr. Khalil Thomas
425-392-9180
Manufacturer Reason
for Recall		 Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
FDA Determined
Cause 2		 Software change control
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 usd-complaint.team@siemens-healthineers.com
Quantity in Commerce 15 systems
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = Siemens Medical Solutions USA, Inc.
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