Z-1375-2013Class II

QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual...

Name: Z-1375-2013 QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual...
Creator: Intel-GE Care Innovations LLC
Published: 2013-04-04
License: https://open.fda.gov/license/

Intel-Ge Care Innovations, LLC / initiated 2013-04-04 / Terminated / root cause: software

FDA source

Intel-GE Care Innovations LLC began a recall of QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community on 2013-04-04. FDA classified it as Class II and gives the reason as "Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1375-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-04
Posted: 2013-05-24
Terminated: 2013-06-04
Recalling firm: Intel-Ge Care Innovations, LLC
Product: QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Product code: IQA System, Environmental Control, Powered
Reason for recall: Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
Root cause tag: software
FDA root cause: Software design
Action: Care Innovations contacted their customers by phone and e-mail regarding the potential problems and fixes on April 4, 17, and 23, 2013. The information provided stated the product, problem, and actions to be taken by the customers. Contact Technical Support at 855-885-2273 for questions regarding this issue.
Quantity in commerce: 1722S; 99 Out of US
Distribution: US and Great Britain
Product codes and lots: US QuietCare: QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 UK QuietCare: QCE200403, v.02; QCE200403, v.03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1375-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1374-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1375-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24

Product code IQA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)