Date Initiated by Firm | March 26, 2010 |
Date Posted | July 01, 2010 |
Recall Status1 |
Terminated 3 on September 16, 2011 |
Recall Number | Z-1945-2010 |
Recall Event ID |
55186 |
510(K)Number | K873806 |
Product Classification |
Bed-Patient Monitor - Product Code KMI
|
Product | Tabs Professional Monitor Without Wall Bracket, Model 25023. Stanley Senior Technologies, Lincoln, NE. |
Code Information |
Serial numbers 236662 thru 236697. |
Recalling Firm/ Manufacturer |
Stanley Security Solutions, Inc. 1550 N 20th Cir Lincoln NE 68503
|
For Additional Information Contact | Michael J. Balters 402-742-9344 |
Manufacturer Reason for Recall | Product might not indicate low battery alarms or exit alarms when powered by a DC power supply. |
FDA Determined Cause 2 | Component change control |
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. |
Quantity in Commerce | 36 units |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = KMI
|