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Health Canada Medical devices

Cardiohelp-i

Issued December 4, 2023
Issue
The quality issue under investigation is applicable to the "connection cable venous probe, l0.23m". The part causing the nonconformance under investigation is responsible for data transmission between the Cardiohelp-i and the venous probe. A noticeable high number of breaks in the insulation sheath and a shielding breach of the venous probe connection cable was observed. Recall Start Date: November 21, 2023
Hazard description
Performance
Product
Product name
Cardiohelp-i
Reference
ID
RA-74679