FDA-Device2024-01-03Class II
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Hazard
Unintended movement of bed wheels
Sold states
US: TN, CA, NY, IL, NV, PA, SD
Affected count
83 units
Manufactured in
Ul. Ks. Piotra Wawrzyniaka 2, Komorniki, Poland
Products
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0611-2024Don't want to check this manually?
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