CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report

QuietCare-Networked. Intended for use recalled

Intel-GE Care Innovations is recalling QuietCare-Networked. Intended for use in monitoring the environmental. The recall was initiated on 4 Apr 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesQuietCare-Networked: Facility Server QC101601

Quantity recalled46

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-1374-2013
FDA event ID: 65031
Recalling firm: Intel-GE Care Innovations, Roseville, CA
Classification: Class II
Status: Terminated
Recall initiated: 4 Apr 2013
FDA classified: 24 May 2013
Reported: 5 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

4 Apr 2013	Recall initiated by company
24 May 2013	Classified by FDA	+50 days
5 Jun 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

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

Product as listed by the FDA

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

Where it was distributed

US and Great Britain

Questions about this recall

Why was it recalled?

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

Which lots are affected?

QuietCare-Networked: Facility Server QC101601

Where was it sold?

US and Great Britain

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

Other products in this recall event

1 other product · FDA event 65031

This product is part of a recall event; the main page for the event is QuietCare. Intended for use recalled by Intel-GE Care Innovations.

Reported	Class	Recall	Company	Reason	Where
5 Jun 2013	CLASS II	QuietCare. Intended for use recalled by Intel-GE Care Innovations	Intel-GE Care Innovations	Other	CA

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. Intended for use recalled by Intel-GE Care Innovations	Intel-GE Care Innovations	Other	CA
6 Mar 2013Device	CLASS II	QuietCare-Networked product, Facility Server recalled	Intel-GE Care Innovations	Device Malfunction	Nationwide

Other Patient Monitors recalls

All 1,013

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9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide