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U.S. Department of Health and Human Services

Class 2 Device Recall Remmers (formerly SnoreSat)

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  Class 2 Device Recall Remmers (formerly SnoreSat) see related information
Date Initiated by Firm May 08, 2008
Date Posted July 11, 2013
Recall Status1 Terminated 3 on July 22, 2013
Recall Number Z-1725-2013
Recall Event ID 65148
510(K)Number K002159  
Product Classification Ventilatory effort recorder - Product Code MNR
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.
Code Information Model: 1.1 Lot numbers: 13367 and 13710
Recalling Firm/
Manufacturer		 SagaTech Electronics, Inc.
9, 1515 Highfield Crescent SE
Calgary Canada Alberta
For Additional Information Contact Melodie Turner
403-228-4214 Ext. 234
Manufacturer Reason
for Recall		 The outer jacket is receding away from the black sensor prematurely.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MNR and Original Applicant = SAGATECH ELECTRONICS, INC.
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