FDA recall Z-0612-2024

ARJOHUNTLEIGH POLSKA Sp. z.o.o. · Class II · device

Product

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

Reason for recall

Unintended movement of bed wheels

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2023-08-29
Report date: 2024-01-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Komorniki, Poland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0612-2024