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Health product recall

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

  1. ICON+ Auto CPAP
  2. ICON+ PREMO CPAP
  3. 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