Health product recall

Acuson Sequoia Diagnostic Ultrasound System

Last updated

Summary

Product
Acuson Sequoia Diagnostic Ultrasound System
Issue
Medical devices - Inaccurate test or measurement results
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or serial number Model or catalog number
Acuson Sequoia Diagnostic Ultrasound System 800343 11148775

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Siemens Medical Solutions Usa, Inc.
22010 Se 51st Street, Issaquah, Washington, United States, 98029
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63779