Recall Z-1349-2019 ยท KMI Monitor, Bed Patient
Stanley Security Solutions Inc
M200 Fall Monitoring System
| Date | Oct 11, 2018 |
| Status | Terminated |
| Reason | Damaged capacitor on the printed circuit board. |
| Root cause | Under Investigation by firm |
| Action | On October 11, 2018 Stanley Healthcare sent via e-mail notification of the recall with the following instructions: PLEASE IMPLEMENT THE FOLLOWING PROCEDURE IMMEDIATELY: 1. Contact Stanley at 800-206-1045 immediately to begin locating affected monitors and to request replacement monitors. Stanley is prepared to provide you with the shipping and order information for the order(s) that may be affected. Any affected monitors that are not in use should be quarantined immediately for return and should not be placed in service. Additionally, if you distributed this monitor to others, please identi |
| Quantity | 1101 |
| Distribution | CT, FL, OH, OK, TX, WA, and WV Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.