FDA Enforcement Class II Terminated

Tabs Professional Monitor, includes one wall bracket, Model 25022. 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-2488-2012 · Reported October 10, 2012

Enforcement

Recall Number
Z-2488-2012
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, includes one wall bracket, Model 25022. 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 235388 thru 268275

Distribution

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

Quantity

2,754 units