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Health Canada Medical devices

Acuson Sequoia Diagnostic Ultrasound System

Issued December 31, 2021
Issue
System overestimates the circumference when the manual trace function is used. the trace circumference value is overestimated; however, the area value is accurate. the issue is present in Sequoia's VA20A/VA25 onward as the VA20A introduced a new calculation design that did not include an optimization step of discarding pixel points that are too close together, causing the close pixel points into the accumulated circumference/distance value makes the final value highly sensitive to small trackball motions. Recall start date: 2021-12-16
Hazard description
Inaccurate test or measurement results
Product
Product name
Acuson Sequoia Diagnostic Ultrasound System
Reference
ID
RA-63779