Z-1725-2013Class II

Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and...

Name: Z-1725-2013 Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and...
Creator: SagaTech Electronics, Inc.
Published: 2008-05-08
License: https://open.fda.gov/license/

Sagatech Electronics, Inc. / initiated 2008-05-08 / Terminated / root cause: manufacturing process

FDA source

SagaTech Electronics, Inc. began a recall of Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study on 2008-05-08. FDA classified it as Class II and gives the reason as "The outer jacket is receding away from the black sensor prematurely". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1725-2013
Classification: Class II
Status: Terminated
Initiated: 2008-05-08
Posted: 2013-07-11
Terminated: 2013-07-22
Recalling firm: Sagatech Electronics, Inc.
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.
Product code: MNR Ventilatory Effort Recorder
Reason for recall: The outer jacket is receding away from the black sensor prematurely.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 152 units 77 devices from lot 13367 and 75 devices from lot 13710
Distribution: Worldwide Distribution: US (nationwide)¿and countries of: ¿Canada and Mexico.
Product codes and lots: Model: 1.1 Lot numbers: 13367 and 13710

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1725-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1725-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11

Product code MNR

K002159Class IISnore Sat Recorder, Model Ss41Sagatech Electronics, Inc. / cleared 2002-06-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)