Recall Z-0611-2024— ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Class II · Ongoing
Class II FDA medical device recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., initiated 2023-08-29. FDA's recall record names no specific 510(k) clearance for this event. 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: Unintended movement of bed wheels.
- Recalling firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-29
- Firm location
- Komorniki, Poland
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.