ClearanceBrief
Recall Z-1856-2011 ยท KMI Monitor, Bed Patient

Stanley Security Solutions, Inc.

Stanley Bed-Check 90-Day LT Chair Sensormat, With 4 Ft. Cord, Model 73001, 5 mats per inner box, 5 inner boxes per overpack box (total 25 units). The firm name on the box is Stanley, 1-800-523-7956. The mat contains only the phone number. For use in reducing patient falls.

DateMar 31, 2011 (initiated Nov 25, 2009)
StatusTerminated
ReasonThe cord could come loose from the mat potentially causing a short to the internal wiring.
Root causeProcess change control
ActionThe firm, Stanley Healthcare Solutions, issued an "Important Technical Bulletin" dated November 25, 2009 to all customers via e-mail. In addition, the firm issued a "Compliance Notice" dated August 30, 2010 via certified mail because the firm had not collected all of the units with the defect. The bulletin described the product, problem and actions to be taken. The customers were instructed to check the cords on the mats to make sure they weren't pulled out, if the cords were pulled out, they were to return the mats for replacement; contact Customer Service at 1-800-824-2996 ext: 3440 to ob
Quantity4,195 mats
DistributionWorldwide distribution: USA and the country of Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.