Medical device recalls Moderate risk

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

Recall date
August 13, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3098-2024
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 DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

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