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U.S. Department of Health and Human Services

Class 2 Device Recall Tabs Professional Monitor, Model 25025

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  Class 2 Device Recall Tabs Professional Monitor, Model 25025 see related information
Date Initiated by Firm March 26, 2010
Date Posted July 01, 2010
Recall Status1 Terminated 3 on September 16, 2011
Recall Number Z-1946-2010
Recall Event ID 55186
510(K)Number K873806  
Product Classification Bed-Patient Monitor - Product Code KMI
Product Tabs Professional Monitor Without Pull Cord or wall bracket, Model 25025, Stanley Senior Technologies, Lincoln, NE.
Code Information Serial numbers 236920 thru 236941
Recalling Firm/
Manufacturer		 Stanley Security Solutions, Inc.
1550 N 20th Cir
Lincoln NE 68503
For Additional Information Contact Michael J. Balters
402-742-9344
Manufacturer Reason
for Recall		 Product might not indicate low battery alarms or exit alarms when powered by a DC power supply.
FDA Determined
Cause 2		 Component change control
Action The firm made phone calls beginning 3/26/10 to customers who purchased the 12-volt power supply informing them of the recall and instructing them to determine the number of units that will need to be returned for replacement. Important Safety Notice letters dated 3/25/10 were issued via regular mail on 3/26/10 and also providing the reason for the recall, instructions, and customer service contact information to arrange for return of the units.
Quantity in Commerce 22 units
Distribution Nationwide Distribution
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 = KMI and Original Applicant = JD MONITORING C/O MACKLER, COOPER AND GIBBS
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