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Open, Classified

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

FDA Recall Z-0612-2024 · Posted 2023-12-22

Recalling FirmARJOHUNTLEIGH POLSKA Sp. z.o.o.
Recall StatusOpen, Classified
Product CodeFNL
Date Initiated2023-08-29
Product Quantity846 units

Reason for Recall

Unintended movement of bed wheels

Firm Action

Arjo issued an URGENT MEDICAL DEVICE RECALL NOTICE to its consignees on 08/29/2023 via US mail. The notice explained the problem with the device and provided instructions for risk mitigation until a permanent technical solution to the issue is available.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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