Z-2471-2021Class II

ACUSON Juniper Diagnostic Ultrasound System

Name: Z-2471-2021 ACUSON Juniper Diagnostic Ultrasound System
Creator: Siemens Medical Solutions USA, Inc.
Published: 2021-07-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-07-12 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of ACUSON Juniper Diagnostic Ultrasound System on 2021-07-12. FDA classified it as Class II and gives the reason as "Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2471-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-12
Posted: 2021-09-14
Terminated: 2024-10-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ACUSON Juniper Diagnostic Ultrasound System
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
Root cause tag: software
FDA 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 [email protected]
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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2471-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2471-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-14

Product code IYN

K201130Class IIACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. / cleared 2020-05-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)