Tabs Professional Monitor Without Pull Cord or wall bracket, Model 25025, Stanley Senior Technologies, Lincoln, NE.
FDA device recall Z-1946-2010 · posted 2010-07-01 · Terminated
Recall details
- Recalling firm
- Stanley Security Solutions, Inc.
- Reason for recall
- Product might not indicate low battery alarms or exit alarms when powered by a DC power supply.
- Action taken
- 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
- Status
- Terminated
- Product code
- KMI
- Quantity affected
- 22 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-03-26
- Date posted
- 2010-07-01
- Date terminated
- 2011-09-16
- Location
- Lincoln, NE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JDM SP2 SENSOR (K873806) | Jd Monitoring C/O Mackler, Cooper and Gibbs | 1987-12-08 |