FDA Recall Terminated

QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.

Recall: Z-1615-2012 · Initiated July 30, 2011

Recall

Recall Number
Z-1615-2012
Event Number
61719
Firm
Intel-GE Care Innovations LLC
FEI Number
3008850109
Product Code
IQA
Status
Terminated
Root Cause
Employee error
Initiated
July 30, 2011
Posted
May 16, 2012
Terminated
May 21, 2012
Address
3721 Douglas Blvd, Ste 100, Roseville, CA, 95661-4243

Description

QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.

Reason

The QuietCare production system experienced a partial outage on 7/29/11. As a result of the partial outage, some monitoring data about residents' movements was not processed in the production system, and alerts were therefore not sent to caregivers. The problem was identified and corrected and the unprocessed data was recovered and processed. However, because of the time lag in processing, a fe

Action

Initial notification to the affected facilities was done by telephone or email on 7/30/11. This was followed up with Urgent Field Notification letters to the customers on 8/12/11 via e-mail. For questions, customers were instructed to contact Customer Support at 1 (866) 772-8243.

Distribution

Worldwide distribution - USA and the United Kingdom.

Quantity

82 units affected by the outage: Domestic - 80 units, Foreign - 2 units