WS80A Diagnostic Ultrasound System, HS70A Ultrasonic Diagnostic Apparatus (2019-06-24)

Starting date:

June 24, 2019

Posting date:

July 5, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70375

Last updated: 2019-07-05

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  Reason
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  Affected products

Affected Products

1. WS80A Diagnostic Ultrasound System
2. HS70A Ultrasonic Diagnostic Apparatus

Reason

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.

Affected products