FDA-Device2024-07-03Class I
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
Baxter Healthcare Corporation
Hazard
Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging.
Sold states
US Nationwide distribution.
Affected count
2,510 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2140-2024Don't want to check this manually?
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