FDA recall Z-3099-2024

Product

Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

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-3099-2024