Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive
FDA device recall Z-0611-2024 · posted 2023-12-22 · Open, Classified
Recall details
- Recalling firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Reason for recall
- Unintended movement of bed wheels
- Action taken
- 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
- Status
- Open, Classified
- Product code
- FNL
- Quantity affected
- 83 units
- Distribution
- US: TN, CA, NY, IL, NV, PA, SD
- Date initiated
- 2023-08-29
- Date posted
- 2023-12-22
- Location
- Komorniki, Poland
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