FDA-Device2024-09-18Class II
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
Zoe Medical Incorporated
Hazard
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.
Sold states
awaiting additional details
Affected count
1506 units
Manufactured in
460 Boston St, Topsfield, MA, United States
Products
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3099-2024Don't want to check this manually?
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