Zoe Medical Incorporated: Device Recall

Recall #Z-3098-2024 · 08/13/2024

Class II: Risk

Recall Details

Recall Number
Z-3098-2024
Classification
Class II
Product Type
Device
Recalling Firm
Zoe Medical Incorporated
Status
Ongoing
Date Initiated
08/13/2024
Location
Topsfield, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6429 units

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.

Product Description

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

Distribution Pattern

awaiting additional details

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.