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
550010550011550015550016550018550019550020550021550023550024550025550026550027550028550029550030550031550032550033550034550035550036550037550038550039550040550041550042550043550044550046550047550048550049550050550051550052550055550056550057550058550059550062550063550064550065550066550067550068550069550070550071550072550073550074550075550077550079550082550083
- Serial Numbers
- 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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