Intel-GE Care Innovations LLC
Intel-GE Care Innovations LLC appears in FDA public data with 4 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2442-2018, Class II) was initiated on December 6, 2017. Its most recent 510(k) clearance was granted on October 8, 2013.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 3
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2442-2018 | Class II | Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobil | December 6, 2017 |
| Z-1375-2013 | Class II | QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of a | April 4, 2013 |
| Z-1374-2013 | Class II | QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (mo | April 4, 2013 |
| Z-0877-2013 | Class II | QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended | December 16, 2012 |