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Health Canada Medical devices

Cardiohelp-I

Issued September 11, 2023
Issue
It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force. Insufficient securement of the slide rails to the lateral aspects to Cardiohelp could provide an opportunity of both/either the transport guard and/or the emergency drive (with the holder) to detach from Cardiohelp. This issue is serial # specific. Recall Start Date: August 29, 2023
Hazard description
Performance
Product
Product name
Cardiohelp-I
Reference
ID
RA-74247