FDA Enforcement Class II Terminated

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.

Recall: Z-2489-2012 · Reported October 10, 2012

Enforcement

Recall Number
Z-2489-2012
Event ID
61796
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Stanley Security Solutions, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Report Date
October 10, 2012
Initiation Date
May 4, 2012
Classification Date
September 28, 2012
Termination Date
September 24, 2013
Address
4600 Vine St, N/A, Lincoln, NE, 68503-2823, United States

Description

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.

Reason

The monitor may fail to sound an alarm

Code Info

Serial numbers 236662 thru 265692

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Canada and Great Britain.

Quantity

4,749 units