FDA-Device2025-02-26Class II
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
Augustine Temperature Management, LLC
Hazard
There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
Sold states
US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
Affected count
3 units
Manufactured in
15305 Minnetonka Blvd, N/A, Minnetonka, MN, United States
Products
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1199-2025Don't want to check this manually?
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