FDA-Device2013-07-17Class II
Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.
SagaTech Electronics, Inc.
Hazard
The outer jacket is receding away from the black sensor prematurely.
Sold states
Worldwide Distribution: US (nationwide)¿and countries of: ¿Canada and Mexico.
Affected count
152 units 77 devices from lot 13367 and 75 devices from lot 13710
Manufactured in
9, 1515 Highfield Crescent SE, N/A, Calgary, Alberta, Canada
Products
Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1725-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief