Health product recall

Stellar 100 and Stellar 150 (2019-12-05)

Starting date:
December 5, 2019
Posting date:
December 20, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-71937

Last updated: 2019-12-20

Affected Products

Stellar 100 and Stellar 150

Reason

Resmed received a confirmed case of an alarm buzzer not working under the following circumstances:  the device has a failed electronic component and, the device is stored without AC power connected for more than 36 hours leading to full depletion of the battery and, the device powers on automatically when connected to AC power without pressing the power switch.  The identified issue is a combination of software and a component failure that may occur in a small number of devices.  If a device with is issue is used in the condition described above, the audible alarms may not operate properly.

Affected products

Stellar 100 and Stellar 150

Lot or serial number

20160123307 to 22171057208

Model or catalog number

24140
24157
24161
24163
24171

Companies
Manufacturer

Resmed Limited

1 Elizabeth Macarthur Drive

Bella Vista

2153

AUSTRALIA