| Class 2 Device Recall ACUSON Juniper ultrasound imaging system | |
Date Initiated by Firm | July 12, 2021 |
Create Date | September 14, 2021 |
Recall Status1 |
Completed |
Recall Number | Z-2471-2021 |
Recall Event ID |
88405 |
510(K)Number | K201130 |
Product Classification |
System, imaging, pulsed doppler, ultrasonic - Product Code IYN
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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;
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Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc. 22010 SE 51st St Issaquah WA 98029-7298
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYN
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