Medical device recalls Moderate risk

Life2000 Ventilation System recalled over fire hazard

Recall date
November 12, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Hill-Rom Manufacturing, Inc. recalls Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: u…
Recall number
Z-0484-2021
FDA classification
Class II
Brand / firm
Hill-Rom Manufacturing, Inc.
Sold / distributed
US Nationwide distribution including in the states of AR, AZ, CA, DE, FL, IL, IN, KY, MN, NC, NM, NV, NY, OH, OK, TX, UT, VA, VT, WI.

Why it was recalled

Under certain conditions, there is a risk for fire.

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

What was recalled

Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.

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