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U.S. Department of Health and Human Services

Class 2 Device Recall Tabs Professional Monitor, Model 25023

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  Class 2 Device Recall Tabs Professional Monitor, Model 25023 see related information
Date Initiated by Firm May 04, 2012
Date Posted September 28, 2012
Recall Status1 Terminated 3 on September 24, 2013
Recall Number Z-2489-2012
Recall Event ID 61796
Product Classification Monitor, bed patient - Product Code KMI
Product Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE.

Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Code Information Serial numbers 236662 thru 265692
Recalling Firm/
Manufacturer		 Stanley Security Solutions, Inc.
4600 Vine St
Lincoln NE 68503-2823
For Additional Information Contact Gina L. Bennett
407-271-2097
Manufacturer Reason
for Recall		 The monitor may fail to sound an alarm
FDA Determined
Cause 2		 Device Design
Action Stanley Security Solutions, Inc. sent an Important Recall Notice dated May 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease using any of the affected product. The customers were informed, however, that they may continue to use the units as long as they were powered with a 9-volt alkaline battery in accordance with current instructions because the issue only occurs when using the 12V DC adaptor. The letter also informs the consignee to expect a follow-up notice no later than 6/1/12 that will provide additional instructions. The recalling firm issued additional letters dated 6/5/12 to distributors and end users with updated instructions. The letter informed them further testing revealed the possibility that a subset of affected monitors may also fail to alarm when powered by a 9V battery if weight is rapidly applied and removed from the pressure pad. Therefore, the recalling firm decided to recall and repair this subset of affected monitors and provided the serial number ranges that must be returned for repair. The letter also provided a list of serial number ranges that could be corrected in the field by permanently blocking access to the 12V DC jack on the monitor. Instructions were enclosed to show the customer how to disable to the jack. In addition the distributor letters request the customer to provide the recall information to their downstream customers. A response form was included to report the amount of affected product in the customers' inventory. For questions customers were instructed to call 888-224-2460. For questions regarding this recall call 407-271-2097.
Quantity in Commerce 4,749 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Canada and Great Britain.
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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