Vital Signs Devices, a GE Healthcare Company
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 0
- Inspections
- 1
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1959-2013 | Class II | Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Sign | July 18, 2013 |
| Z-0330-2013 | Class II | Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) | October 16, 2012 |
| Z-1972-2012 | Class II | enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MO | February 20, 2012 |