Z-0877-2013Class II

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

Name: Z-0877-2013 QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and...
Creator: Intel-GE Care Innovations LLC
Published: 2012-12-16
License: https://open.fda.gov/license/

Intel-Ge Care Innovations, LLC / initiated 2012-12-16 / Terminated / root cause: software

FDA source

Intel-GE Care Innovations LLC began a recall of QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements on 2012-12-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0877-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-16
Posted: 2013-02-23
Terminated: 2013-02-26
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.
Product code: KMI Monitor, Bed Patient
Reason for recall: 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 tag: software
FDA 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 in commerce: 19 units
Distribution: Nationwide Distribution.
Product codes and lots: All units of this model.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0877-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0877-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-22

Product code KMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)