FDAClass IIMarch 6, 2013

QuietCare-Networked product recall: Software Issue

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

Why was QuietCare-Networked product recalled?

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.

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?

All units of this model.

Product
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Recalling firm
Intel-GE Care Innovations LLC
Quantity
19 units
Distribution
Nationwide Distribution.
Recall date
March 6, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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