Reported Mar 23, 2022 · Ongoing

Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging…

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc. · 22010 SE 51st St · Issaquah, WA · 98029-7298

Is this the product you have?

  • Diagnostic Ultrasound System, ACUSON Juniper
  • UDI(01)04056869152059
  • Model11335791, Rx, CE Ultrasound imaging system
  • intended for the following applicationsVascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications
Lot codes and dates
  • Serial Numbers

    2,846 of 2,846 codes

    • 550010
    • 550011
    • 550015
    • 550016
    • 550018
    • 550019
    • 550020
    • 550021
    • 550023
    • 550024
    • 550025
    • 550026
    • 550027
    • 550028
    • 550029
    • 550030
    • 550031
    • 550032
    • 550033
    • 550034
    • 550035
    • 550036
    • 550037
    • 550038
    • 550039
    • 550040
    • 550041
    • 550042
    • 550043
    • 550044
    • 550046
    • 550047
    • 550048
    • 550049
    • 550050
    • 550051
    • 550052
    • 550055
    • 550056
    • 550057
    • 550058
    • 550059
    • 550062
    • 550063
    • 550064
    • 550065
    • 550066
    • 550067
    • 550068
    • 550069
    • 550070
    • 550071
    • 550072
    • 550073
    • 550074
    • 550075
    • 550077
    • 550079
    • 550082
    • 550083
Amount recalled
2846

Where it was sold

  • Nationwide

Why it was recalled

The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.