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Terminated

Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.

FDA Recall Z-1725-2013 · Posted 2013-07-11

Recalling FirmSagaTech Electronics, Inc.
Recall StatusTerminated
Product CodeMNR
Date Initiated2008-05-08
Date Terminated2013-07-22
Product Quantity152 units 77 devices from lot 13367 and 75 devices from lot 13710

Reason for Recall

The outer jacket is receding away from the black sensor prematurely.

Firm Action

SagaTech Electronics Inc, sent a letter to their Customers dated May 2008. The letter identified the product the problem and the action needed to be taken by the customer. Please take particular attention when cleaning these sensors by holding the cable somewhere in the middle and clean towards each end. This should become standard practice with all sensors to prolong their lifespan. If you have further questions please call (403) 228-4214 ext. 234.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution: US (nationwide)¿and countries of: ¿Canada and Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002159SNORE SAT RECORDER, MODEL SS41Sagatech Electronics, Inc. · 2002-06-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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