QuietCare-Networked product — Class II medical device recall Z-0877-2013
Terminated recall by Intel-GE Care Innovations LLC, reported 2013-03-06, distributed nationwide. Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wan
| Recall number | Z-0877-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intel-GE Care Innovations LLC, Roseville, CA, United States |
| Recall initiated | 2012-12-16 |
| Classified | 2013-02-22 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2013-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 19 units |
| Reason classes | software |
| Model numbers | QC101601 |
Product
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0877-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.