Prodigy Sleep System HMU & CMU (2020-04-08)
- Starting date:
- April 8, 2020
- Posting date:
- May 1, 2020
- 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-72929
Last updated: 2020-05-01
Affected Products
A. Prodigy Sleep System HMU
B. Prodigy Sleep System CMU
Reason
TTU software is unable to process audio samples fast enough and samples are dropped instead of buffered. This leads to missing samples, with no way to reconstruct the original audio signal. This can lead to underreporting of snoring events in a sleep study
Affected products
A. Prodigy Sleep System HMU
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 100099
Companies
- Manufacturer
-
Cerebra Medical
1470 Willson Place, Unit B
Winnipeg
R3T 3N9
Manitoba
CANADA
B. Prodigy Sleep System CMU
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 100100
Companies
- Manufacturer
-
Cerebra Medical
1470 Willson Place, Unit B
Winnipeg
R3T 3N9
Manitoba
CANADA