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

Recall date

August 13, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3099-2024

FDA classification

Class II

Brand / firm

Zoe Medical Incorporated

Sold / distributed

awaiting additional details

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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