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U.S. Department of Health and Human Services

Class 2 Device Recall Sensatec ST500

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  Class 2 Device Recall Sensatec ST500 see related information
Date Initiated by Firm December 16, 2002
Date Posted January 16, 2003
Recall Status1 Terminated 3 on July 31, 2003
Recall Number Z-0446-03
Recall Event ID 25279
Product Classification Monitor, Bed Patient - Product Code KMI
Product Bed/chair alarm
Code Information All units produced
Recalling Firm/
Manufacturer		 RF Technologies, Inc.
3125 N. 126th Street
Brookfield WI 53005
Manufacturer Reason
for Recall		 In some cases the unit appears to be monitoring the patient, when in fact the alarm is silenced.
FDA Determined
Cause 2		 Other
Quantity in Commerce 113
Distribution Nationwide
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.
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