medical Class II Updated 2024-10-02

Siemens Medical Solutions USA, Inc. recalls ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Syst

Recalled Product

ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.

Hazard / Issue

If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management

Issued by

FDA

Affected States: MS, WA, TX, NJ, GA, NY, AL, MN, NE, IN, CT, CA, IL, TN, WI, ND, NM, AR, NC, RI, WY, MD, FL, HI, AZ, SC, MO, OK, VA, ME, KS, MI, LA, IA, OH, SD, NH, KY, OR, MA

Lot/Code Info: 11335791, UDI-DI: 04056869152059: 1.0/VA10G and prior, 1.5/ VB10H and prior , 2.0/ VB11C and prior, 2.5/ VB30D and prior. 11653093, UDI-DI: 04056869957357: 2.0/ VB11C and prior, 2.5/ VB30D and prior.

View official government recall

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