Class II

Medical Device Recall: 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. · August 29, 2023

Reason for Recall

Unintended movement of bed wheels

Distribution

US: TN, CA, NY, IL, NV, PA, SD

States Affected

CA, IL, NV, NY, PA, SD, TN

Quantity Affected

83 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0611-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.