CLASS II Device recall · Reported 6 Mar 2013 · FDA Enforcement Report

QuietCare-Networked product, Facility Server recalled

Intel-GE Care Innovations is recalling QuietCare-Networked product, Facility Server, distributed nationwide in the US. The recall was initiated on 16 Dec 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll units of this model.

Quantity recalled19 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0877-2013
FDA event ID: 63957
Recalling firm: Intel-GE Care Innovations, Roseville, CA
Classification: Class II
Status: Terminated
Recall initiated: 16 Dec 2012
FDA classified: 22 Feb 2013
Reported: 6 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

16 Dec 2012	Recall initiated by company
22 Feb 2013	Classified by FDA	+68 days
6 Mar 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the implementation of the Wander and Night Motion ADLs was discovered.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is QuietCare-Networked product, Facility Server recalled?

Yes. Intel-GE Care Innovations recalled QuietCare-Networked product, Facility Server on 16 Dec 2012. The recall is Class II and its status is Terminated. Recall number Z-0877-2013.

Why was it recalled?

Which lots are affected?

All units of this model.

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Intel-GE Care Innovations

All 4

Reported	Class	Recall	Company	Reason	Where
25 Jul 2018Device	CLASS II	Health Harmony Mobile application recalled by Intel-GE Care Innovations	Intel-GE Care Innovations	Device Malfunction	Nationwide
5 Jun 2013Device	CLASS II	QuietCare-Networked. Intended for use recalled	Intel-GE Care Innovations	Other	CA
5 Jun 2013Device	CLASS II	QuietCare. Intended for use recalled by Intel-GE Care Innovations	Intel-GE Care Innovations	Other	CA

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