Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classification Name: System, Envi

FDA device recall Z-1703-2012 · posted 2012-06-05 · Terminated

Recall details

Recalling firm

Intel-GE Care Innovations LLC

Reason for recall

On 7/29/11, the QuietCare production system experienced a partial outage from about 15:00 hours until 22:30. During the engineering investigation into the cause of the service disruption, it was discovered that some residents did not have the wander and night motion features properly activated, and alerts were not being transmitted. Failure to generate alerts in a timely manner could result in a

Action taken

Intel-GE Care Innovations sent an "URGENT FIELD NOTIFICATION" e-mail dated August 12, 2011 to all affected customers. The notification identifies the product and problem. No action is required by the customers. Contact Customer Service at (866) 772-8243 for questions regarding this notice.

Root cause

Employee error

Status

Terminated

Product code

IQA

Quantity affected

61 units were identified as affected

Distribution

Nationwide Distribution-USA (nationwide) including the states of Arizona, California, Connecticut, Idaho, Illinois, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Texas, and Utah.

Date initiated

2011-08-01

Date posted

2012-06-05

Date terminated

2012-06-05

Location

Roseville, CA