Topsfield, MA, United States
Zoe Medical Incorporated recalls
1 recall recorded since 2018, most recently on 13 August 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 August 2024
- Reason
- This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
- Distribution
- awaiting additional details
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3098-2024, Z-3099-2024
- Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
- Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.