Zoe Medical Incorporated
Zoe Medical Incorporated has 3 FDA recalls, 5 inspections, 5 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-3099-2024 · Class II · Aug 13, 2024
- Latest inspection
- May 31, 2024 · VAI
- Latest 510(k)
- Feb 15, 2021
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 3 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 5 | Oct 4, 2026 | Not stated | Current |
| Inspections | 5 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-3099-2024 | Class II | Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW)… | Aug 13, 2024 |
| Z-3098-2024 | Class II | Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330 | Aug 13, 2024 |
| Z-2380-2012 | Class II | Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated… | Jun 6, 2012 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 31, 2024 | Topsfield, MA | Devices | Voluntary Action Indicated (VAI) | 3003294644 |
| Sep 20, 2019 | Topsfield, MA | Devices | Voluntary Action Indicated (VAI) | 3003294644 |
| Oct 12, 2016 | Topsfield, MA | Devices | No Action Indicated (NAI) | 3003294644 |
| Feb 7, 2013 | Topsfield, MA | Devices | Voluntary Action Indicated (VAI) | 3003294644 |
| Apr 20, 2010 | Topsfield, MA | Devices | Voluntary Action Indicated (VAI) | 3003294644 |