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Health Canada Medical devices

Infinity® Central Station

Issued March 22, 2023
Issue
During our global market surveillance activities, we have become aware of cases in which the software on the Infinity® Central Station drops peaks on narrow waveforms causing the Infinity® M300 to fail the requirements of the standard IEC 60601-2-27. Recall start date: March 9, 2023
Hazard description
Performance
Product
Product name
Infinity® Central Station
Reference
ID
RA-73365