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Recall Observatory FDA recall evidence

Device product

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

Z-1375-2013

April 04, 2013

Class II

Product summary

Firm
Intel-GE Care Innovations LLC
Event
Event 65031
Status
Terminated
Classification
Class II
Quantity
1722S; 99 Out of US
Official record key
device-enforcement:Z-1375-2013

Official wording

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

Code information: US  QuietCare: QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 UK  QuietCare: QCE200403, v.02; QCE200403, v.03

Distribution pattern: US and Great Britain

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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