The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1374-2013·Announced 2013-06-05

Intel-GE Care Innovations Recalls QuietCare-Networked Monitoring Devices

Intel-GE Care Innovations is recalling 46 QuietCare-Networked devices due to duplicate alerts. The devices are used to monitor senior housing residents.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to duplicate alerts, which is a functional defect rather than a direct physical safety risk, fitting the criteria for a moderate severity recall.

Plain-English summary

Intel-GE Care Innovations LLC is recalling 46 units of the QuietCare-Networked product. This device is intended for monitoring the environmental conditions and activity of individuals living in senior housing communities. The recall was initiated because customers at four facilities reported receiving duplicate alerts from the system.

The affected units were distributed in the United States and Great Britain. The specific code for the recalled facility server is QC101601. The recall is classified as Class II by the U.S. Food and Drug Administration.

Consumers and facility managers should contact Intel-GE Care Innovations LLC for instructions on how to resolve the issue with the duplicate alerts. No injuries or illnesses have been reported in connection with this recall.

The recalled product

Product
QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Manufacturer
Intel-GE Care Innovations LLC
Category
Medical Device — Monitoring Device
Hazard
Affected units
46

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • QuietCare-Networked: Facility Server QC101601

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Intel-GE Care Innovations LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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