Recall Z-2471-2021 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON Juniper Diagnostic Ultrasound System
| Date | Jul 12, 2021 |
| Status | Terminated |
| Reason | Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable. |
| Root cause | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201130 | ACUSON Juniper Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc., May 26, 2020 |