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Icon + Auto, ICON + Premo, ICON + Novo CPAP Units
- Starting date:
- April 22, 2013
- Posting date:
- July 23, 2013
- 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-34689
Recalled products
- ICON+ Auto CPAP
- ICON+ PREMO CPAP
- ICON+ NOVO CPAP
Reason
Fisher and Paykel Healthcare has become aware that there is a potential power issue on certain icon CPAP units. These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained.
Affected products
A. ICON+ Auto CPAP
Lot or serial number
- 121212
- 121213
- 121214
- 121215
- 121217
- 121218
- 121220
- 121221
Model or catalog number
- ICONAAN
- ICONAAN-HT
Companies
- Manufacturer
-
Fisher and Paykel Healthcare Ltd.
15 Maurice Paykel Place East Tamaki, P.O. Box 14348 Panmure
Auckland
2013
NEW ZEALAND
B. ICON+ PREMO CPAP
Lot or serial number
- 121210
- 121211
- 121213
- 121215
- 121218
- 121219
- 121220
- 121221
Model or catalog number
- ICONPBN
- ICONPBN-HT
- ICONPBN-HTC
Companies
- Manufacturer
-
Fisher and Paykel Healthcare Ltd.
15 Maurice Paykel Place East Tamaki, P.O. Box 14348 Panmure
Auckland
2013
NEW ZEALAND
C. ICON+ NOVO CPAP
Lot or serial number
- 121211
- 121212
- 121213
- 121214
- 121215
- 121218
- 121219
- 121220
- 121221
Model or catalog number
- ICONNAN
- ICONNAN-HT
Companies
- Manufacturer
-
Fisher and Paykel Healthcare Ltd.
15 Maurice Paykel Place East Tamaki, P.O. Box 14348 Panmure
Auckland
2013
NEW ZEALAND