F&P SleepStyle CPAP Device (2018-03-14)
- Starting date:
- March 14, 2018
- Posting date:
- April 3, 2018
- 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-66322
Affected products
F&P SLEEPSTYLE CPAP DEVICE
Reason
A firmware anomaly prevents the F&P SleepStyle from recording clinical data, and may delay remote prescription changes, if the device is continually powered for 20-50 days. This timeframe may vary depending on the number and length of therapy sessions.
Affected products
F&P SLEEPSTYLE CPAP DEVICE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
SPSAAN
Companies
- Manufacturer
-
Fisher and Paykel Healthcare Ltd.
15 Maurice Paykel Place East Tamaki, P.O. Box 14348 Panmure
Auckland
2013
NEW ZEALAND