Product Wiki · Recalls · Health Canada — Medical Devices

WS80A Diagnostic Ultrasound System, HS70A Ultrasonic Diagnostic… — recall 59358

Health Canada — Medical Devices · Canada · 2019-07-05 · Type II

As described by Health Canada — Medical Devices: WS80A Diagnostic Ultrasound System, HS70A Ultrasonic Diagnostic Apparatus (2019-06-24)

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Agency
Health Canada — Medical Devices
Recall identifier
59358
Date of alert
2019-07-05
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: A specific mode of operation of certain versions of WS80A/HS70A systems may pose a risk to patient safety. On June 13, 2019, the manufacturer discovered that probes may overheat when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode on WS80A/HS70A systems. There has been no actual injury reported to Samsung Medison.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ws80a-diagnostic-ultrasound-sy

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