FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: ACUSON Juniper Diagnostic Ultrasound System
- Recall number
- Z-2471-2021
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- ACUSON Juniper Diagnostic Ultrasound System
- Status
- Terminated
- Initiated
- 2021-07-12
- Posted
- not on file
- Terminated
- 2024-10-16
- 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 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
- 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.
- Lot, serial or model codes
- 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;
- 510(k) numbers
- ["K201130"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3023245
- Firm city
- Issaquah
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28