Health product recall

Atlan® A350

Last updated

Summary

Product
Atlan® A350
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number/

Atlan® A350 XL

ASRJ-0212
ASNN-0052

8621600

Atlan® A350

More than 10 numbers, contact manufacturer.

8621500

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Draegerwerk AG & Co. KGaA

Moislinger Allee 53-55, Lubeck, Germany, 23542

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75032

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