medical Class II Updated 2024-10-02

Siemens Medical Solutions USA, Inc. recalls ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750

Recalled Product

ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, 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: 11711750, UDI-DI: 04056869995809, Software VA10A 11711779, UDI-DI: 04056869995830, Software VA10A

View official government recall

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