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Health Canada Medical devices

Atlan® A350

Issued February 7, 2024
Issue
The recall is being initiated as the market surveillance activities revealed a few cases in which the internal backup battery failed spontaneously while the Atlan® is being operated without mains supply. This resulted in an unexpected shutdown of the device while it was running on batteries. The affected Atlans started with a battery status of 100%, but quickly shut down and did not trigger the alarm for low battery. A secondary acoustic alarm signal which is independent from mains and battery power was generated as specified. No patient consequences have been reported to Draeger so far. Recall start date: November 21, 2023
Hazard description
Performance
Product
Product name
Atlan® A350
Reference
ID
RA-75032