Product Wiki · Recalls · Health Canada — Medical Devices

ACUSON SC2000 (2015-07-30) — recall 53651

Health Canada — Medical Devices · Canada · 2015-08-18 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
53651
Date of alert
2015-08-18
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: As a result of in-house product testing, it was discovered that when performing a 2D stress echo study, specific keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study. The issue is present only for users with software versions VA16A and VA30A. It is solved in customers with software version 3.5 (VA35) or 4.0(VA40).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/acuson-sc2000-2015-07-30

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