QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403,

FDA device recall Z-1615-2012 · posted 2012-05-16 · Terminated

Recall details

Recalling firm

Intel-GE Care Innovations LLC

Reason for recall

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 taken

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.

Root cause

Employee error

Status

Terminated

Product code

IQA

Quantity affected

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

Distribution

Worldwide distribution - USA and the United Kingdom.

Date initiated

2011-07-30

Date posted

2012-05-16

Date terminated

2012-05-21

Location

Roseville, CA