FDAJuly 13, 2023device
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
siemens medical solutionssiemenssiemens medical
UPCs
04056869251264
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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