Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Tabs Professional Monitor with Wire Bracket and Push Button Reset, Model 25223, Stanley Senior Technologies, Lincoln, NE.

FDA Recall Z-1947-2010 · Posted 2010-07-01

Recalling FirmStanley Security Solutions, Inc.
Recall StatusTerminated
Product CodeKMI
Date Initiated2010-03-26
Date Terminated2011-09-16
Product Quantity45 units

Reason for Recall

Product might not indicate low battery alarms or exit alarms when powered by a DC power supply.

Firm Action

The firm made phone calls beginning 3/26/10 to customers who purchased the 12-volt power supply informing them of the recall and instructing them to determine the number of units that will need to be returned for replacement. Important Safety Notice letters dated 3/25/10 were issued via regular mail on 3/26/10 and also providing the reason for the recall, instructions, and customer service contact information to arrange for return of the units.

Root Cause

Component change control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K873806JDM SP2 SENSORJd Monitoring C/O Mackler, Cooper and Gibbs · 1987-12-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑