Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada and the United States Food and Drugs Administration (FDA) have posted medical device safety alerts concerning GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Venue Go Standard Carts Ref: (H45181VC and H45103VCW) used with Venue Go R2, R3, R4 systems [HKMD No.: 200438].
According to the authorities, some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling.
For further information, please visit
Health Canada https://recalls-rappels.canada.ca/en/alert-recall/venue-go
The United States Food and Drugs Administration (FDA) https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93069
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 Oct 2023