Device product
Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.
Z-1725-2013
Product summary
- Event
- Event 65148
- Status
- Terminated
- Classification
- Class II
- Quantity
- 152 units 77 devices from lot 13367 and 75 devices from lot 13710
- Official record key
device-enforcement:Z-1725-2013
Official wording
Reason: The outer jacket is receding away from the black sensor prematurely.
Code information: Model: 1.1 Lot numbers: 13367 and 13710
Distribution pattern: Worldwide Distribution: US (nationwide)¿and countries of: ¿Canada and Mexico.
Derived failure modes
-
Unknown
The outer jacket is receding away from the black sensor prematurely.