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
This recall is currently active, issued December 22, 2023. It was issued by Arjohuntleigh Polska Sp. Z.O.O. Ul. Ks. Piotra Wawrzyniaka 2 Komorniki Poland.
- Recall Initiated
- August 29, 2023
- Posted
- December 22, 2023
- Recall Number
- Z-0611-2024
- Quantity
- 83 units
- Official Source
- View on FDA website ↗
Reason for Recall
Unintended movement of bed wheels
Distribution
US: TN, CA, NY, IL, NV, PA, SD
Lot / Code Info
UDI/DI 0505609734548, serial numbers: P0504690, P0504691, P0510813, P0512547, P0512548, P0515453, P0515454, P0515455, P0515456, P0515457, P0516242, P0517649, P0517650, P0517651, P0517652, P0517653, P0517654, P0517655, P0517656, P0517657, P0517658, P0519068, P0525670, P0525671, P0525672, P0525673, P0525674, P0525675, P0525676, P0525677, P0525678, P0525679, P0525680, P0525681, P0525682, P0525683, P0525684, P0525685, P0525686, P0526405, P0526406, P0526407, P0526408, P0526409, P0526410, P0526425, P0526426, P0526427, P0526428, P0526429, P0526430, P0526431, P0526432, P0527297, P0527298, P0527299, P0527300, P0527301, P0527302, P0529533, P0529534, P0529535, P0529536, P0494034, P0494035, P0494036, P0494037, P0494038, P0494039, P0494040, P0494041, P0494042, P0494043, P0494044, P0494045, P0494046, P0494047, P0494048, P0501255, P0501256, P0501257, P0501258, P0501259
Root Cause
Device Design
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.