Vital Signs Devices, a GE Healthcare Company

FDA Regulatory Profile

Vital Signs Devices, a GE Healthcare Company appears in FDA public data with 3 recalls, 0 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (Z-1959-2013, Class II) was initiated on July 18, 2013.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1959-2013Class IIDisposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital SignJuly 18, 2013
Z-0330-2013Class IICorometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) October 16, 2012
Z-1972-2012Class IIenFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MOFebruary 20, 2012