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Health product recall

Various Medical Devices Recalled by Resmed (2015-04-09)

Starting date:
April 9, 2015
Posting date:
May 8, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-53273

Recalled Products

A. SlimLine
B. AirSense 10 Elite
C. ClimateLine Air
D. AirSense 10 CPAP
E. AirSense 10 AutoSet
F. AirSense 10 AutoSet For Her
G. AirCurve 10 S
H. AirCurve 10 VAuto
I. AirCurve 10 ASV
J. AirCurve 10 ST

Reason

Heated tubing faults were detected in some devices causing a ClimateLineAir error message on the user interface caused by software interpreting static electricity as a fault with the tubing.

Affected products

A. SlimLine

Lot or serial number

Not applicable

Model or catalog number

36810

Companies
Manufacturer
Resmed Limited
1 Elizabeth Macarthur Drive
Bella Vista
2153
AUSTRALIA

B. AirSense 10 Elite

Lot or serial number

Not applicable

Model or catalog number

37205
37206

Companies
Manufacturer
Resmed Limited
1 Elizabeth Macarthur Drive
Bella Vista
2153
AUSTRALIA

C. ClimateLine Air

Lot or serial number

Not applicable

Model or catalog number

37296
37357

Companies
Manufacturer
Resmed Limited
1 Elizabeth Macarthur Drive
Bella Vista
2153
AUSTRALIA

D. AirSense 10 CPAP

Lot or serial number

Not applicable

Model or catalog number

37203
37204

Companies
Manufacturer
Resmed Limited
1 Elizabeth Macarthur Drive
Bella Vista
2153
AUSTRALIA

E. AirSense 10 AutoSet

Lot or serial number

Not applicable

Model or catalog number

37207
37208

Companies
Manufacturer
Resmed Limited
1 Elizabeth Macarthur Drive
Bella Vista
2153
AUSTRALIA

F. AirSense 10 AutoSet For Her

Lot or serial number

Not applicable

Model or catalog number

37209
37210

Companies
Manufacturer
Resmed Limited
1 Elizabeth Macarthur Drive
Bella Vista
2153
AUSTRALIA

G. AirCurve 10 S

Lot or serial number

Not applicable

Model or catalog number

37213
37214

Companies
Manufacturer
Resmed Limited
1 Elizabeth Macarthur Drive
Bella Vista
2153
AUSTRALIA

H. AirCurve 10 VAuto

Lot or serial number

Not applicable

Model or catalog number

37211
37212

Companies
Manufacturer
Resmed Limited
1 Elizabeth Macarthur Drive
Bella Vista
2153
AUSTRALIA

I. AirCurve 10 ASV

Lot or serial number

Not applicable

Model or catalog number

37215
37216

Companies
Manufacturer
Resmed Limited
1 Elizabeth Macarthur Drive
Bella Vista
2153
AUSTRALIA

J. AirCurve 10 ST

Lot or serial number

Not applicable

Model or catalog number

37306
37307

Companies
Manufacturer
Resmed Limited
1 Elizabeth Macarthur Drive
Bella Vista
2153
AUSTRALIA