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Health Canada Medical devices

Enterprise 9000x With Indigo Module

Issued September 8, 2023
Issue
Arjo has observed an increasing complaint trend on the following failure modes occurring on Arjo medical beds assembled with the Indigo modules: unanticipated device self-acceleration while being operated by a caregiver, unexpected movement without any intentional activation from a stationary position, device movement in a wrong direction (i.e. backwards instead of forwards and vice versa). Recall Start Date: August 23, 2023
Hazard description
Performance
Product
Product name
Enterprise 9000x With Indigo Module
Reference
ID
RA-74242