medical Class II Updated 2023-09-20

Siemens Medical Solutions USA, Inc. recalls ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

Recalled Product

ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

Hazard / Issue

If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 04056869251264. Systems with software version prefix VA20.
View official government recall

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