FDA Medical Device Recalls (openFDA)
Intel-GE Care Innovations LLC: QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
- Recall number
- Z-0877-2013
- Recalling firm
- Intel-GE Care Innovations LLC
- Product
- QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
- Status
- Terminated
- Initiated
- 2012-12-16
- Posted
- 2013-02-23
- Terminated
- 2013-02-26
- Reason
- 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.
- Root cause
- Software design
- Action
- Care Innovations sent a "DEVICE CORRECTION NOTIFICATION" letter dated 12/20/12 to all affected customers. The letter identified the product and problem. Correction was performed remotely by the firm. Contact the firm at 917-232-4775 for questions regarding this notice.
- Quantity
- 19 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- All units of this model.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KMI
- 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