FDA Recall
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
Recall: Z-0612-2024
·
Initiated August 29, 2023
Recall
- Recall Number
- Z-0612-2024
- Event Number
- 93463
- Firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ul. Ks. Piotra Wawrzyniaka 2 Komorniki Poland
- FEI Number
- 3007420694
- Product Code
- FNL
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- August 29, 2023
- Posted
- December 22, 2023
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
Unintended movement of bed wheels
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.
Distribution
US: TN, CA, NY, IL, NV, PA, SD
Quantity
846 units