Z-2490-2012Class II

Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc...

Name: Z-2490-2012 Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc...
Creator: Stanley Security Solutions, Inc.
Published: 2012-05-04
License: https://open.fda.gov/license/

Securitas Healthcare LLC / initiated 2012-05-04 / Terminated / root cause: design

FDA source

Stanley Security Solutions, Inc. began a recall of Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of... on 2012-05-04. FDA classified it as Class II and gives the reason as "The monitor may fail to sound an alarm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2490-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-04
Posted: 2012-09-28
Terminated: 2013-09-24
Recalling firm: Securitas Healthcare LLC
Product: Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. 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.
Product code: KMI Monitor, Bed Patient
Reason for recall: The monitor may fail to sound an alarm
Root cause tag: design
FDA root cause: 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: 176 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Canada and Great Britain.
Product codes and lots: Serial numbers 236920 thru 241732

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2490-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2488-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2489-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2490-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2491-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2492-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28

Product code KMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)