FDA Medical Device Recalls (openFDA)
Intel-GE Care Innovations LLC: QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
- Recall number
- Z-1375-2013
- Recalling firm
- Intel-GE Care Innovations LLC
- Product
- QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
- Status
- Terminated
- Initiated
- 2013-04-04
- Posted
- 2013-05-24
- Terminated
- 2013-06-04
- Reason
- Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
- Root cause
- Software design
- Action
- Care Innovations contacted their customers by phone and e-mail regarding the potential problems and fixes on April 4, 17, and 23, 2013. The information provided stated the product, problem, and actions to be taken by the customers. Contact Technical Support at 855-885-2273 for questions regarding this issue.
- Quantity
- 1722S; 99 Out of US
- Distribution
- US and Great Britain
- Lot, serial or model codes
- US QuietCare: QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 UK QuietCare: QCE200403, v.02; QCE200403, v.03
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IQA
- Firm FEI
- 3008850109
- Firm city
- Roseville
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28