Recall Z-1725-2013— SagaTech Electronics, Inc.

Name: FDA recall Z-1725-2013
Creator: U.S. Food and Drug Administration
Published: 2008-05-08

Class II · Terminated

Class II FDA medical device recall by SagaTech Electronics, Inc., initiated 2008-05-08, terminated 2013-07-22. It names one FDA 510(k) clearance: K002159. 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.. Reason: The outer jacket is receding away from the black sensor prematurely..

Recalling firm: SagaTech Electronics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2008-05-08
Terminated: 2013-07-22
Firm location: Calgary, Alberta, Canada

510(k) clearances named in this recall

1 on FDA's record

K002159 — SNORE SAT RECORDER, MODEL SS41Sagatech Electronics, Inc.·cleared 2002-06-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.