FDAClass IIJune 5, 2013

QuietCare. Intended for use in monitoring the recall

QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.

Why was QuietCare. Intended for use in monitoring the recalled?

Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

US  QuietCare: QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 UK  QuietCare: QCE200403, v.02; QCE200403, v.03

Product
QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Recalling firm
Intel-GE Care Innovations LLC
Quantity
1722S; 99 Out of US
Distribution
US and Great Britain
Recall date
June 5, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls