M200 Fall Monitoring System
FDA Recall Z-1349-2019 · Posted None
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Recalling FirmStanley Security Solutions Inc
Recall StatusTerminated
Product CodeKMI
Date Initiated2018-10-11
Date Terminated2020-04-10
Product Quantity1101
Reason for Recall
Damaged capacitor on the printed circuit board.
Firm Action
On October 11, 2018 Stanley Healthcare sent via e-mail notification of the recall with the following instructions:
PLEASE IMPLEMENT THE FOLLOWING PROCEDURE IMMEDIATELY:
1. Contact Stanley at 800-206-1045 immediately to begin locating affected monitors and to request replacement monitors. Stanley is prepared to provide you with the shipping and order information for the order(s) that may be affected. Any affected monitors that are not in use should be quarantined immediately for return and should not be placed in service. Additionally, if you distributed this monitor to others, please identify them and notify them immediately of this product recall. Please provide them with a copy of this Recall Notice. During this call with Stanley, you will obtain an advance Return Merchandise Authorization number. New monitors will be shipped to you at no charge, and arrangements will be made to return affected monitors to Stanley for further investigation.
2. Return Product through Customer Service
After receiving replacement monitors, replace all affected monitors identified below, and return them to Stanley using the Return Merchandise Authorization number and instructions that were issued to you when replacements were ordered.
3. Certification of Products Return
IMPORTANT! Upon return of all affected monitors, the person in authority at the facility must sign the appropriate acknowledgement signature block listed below and return the fully executed Recall Notice to:
Mr. Garth Jack Sr. QA, EHS, & Compliance Manager 4600 Vine Street
Lincoln, NE 68503 Phone: 402-742-9335
Root Cause
Under Investigation by firm
Distribution Pattern
CT, FL, OH, OK, TX, WA, and WV Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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