Zoe Medical Incorporated

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3099-2024Class IISpacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW),August 13, 2024
Z-3098-2024Class IISpacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330August 13, 2024
Z-2380-2012Class IISpacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated foJune 6, 2012