FDA recall Z-3098-2024

Zoe Medical Incorporated · Class II · device

Product

Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

Reason for recall

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

Key facts

Status
Ongoing
Initiation date
2024-08-13
Report date
2024-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Topsfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3098-2024