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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