Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather hea...
FDA Recall #Z-1725-2013 — Class II — May 8, 2008
Product Description
Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.
Reason for Recall
The outer jacket is receding away from the black sensor prematurely.
Recalling Firm
SagaTech Electronics, Inc. — Calgary, Alberta
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
152 units 77 devices from lot 13367 and 75 devices from lot 13710
Distribution
Worldwide Distribution: US (nationwide)¿and countries of: ¿Canada and Mexico.
Code Information
Model: 1.1 Lot numbers: 13367 and 13710
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated