Arjo medical beds with unintended wheel movement recalled
Arjo medical beds with IndiGo Drive Assistance modules may experience unintended wheel movement. The recall affects 846 units distributed across seven US states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II FDA medical device recall involves a potential safety hazard (unintended wheel movement) affecting critical care equipment with no reported injuries or illnesses. It qualifies as High per the rubric criterion for risk-of-harm products where injury has not yet been reported, falling short of Severe without documented incidents.
Plain-English summary
Arjo is recalling specific medical bed models (Enterprise 5000X, Enterprise 8000X, Enterprise 9000X, and Citadel) that were assembled with or retrofitted with IndiGo Drive Assistance modules. A total of 846 units are affected by this Class II recall.
The recalled beds may experience unintended movement of bed wheels, creating a potential safety hazard in healthcare settings. The issue affects units distributed across Tennessee, California, New York, Illinois, Nevada, Pennsylvania, and South Dakota.
Affected beds can be identified using their UDI codes (050560973512 and 0505609734548) and specific serial numbers. Healthcare facilities should refer to the FDA recall notice for complete serial number lists and further information.
The recalled product
- 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
- Manufacturer
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Category
- Medical Device — Hospital Beds
- Hazard
- unintended-movement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) UDI/DI 050560973512
- serial numbers: P0595355
- P0595356
- P0595357
- P0595358
- P0595359
- P0595360
- P0595361
- P0595362
- P0595363
- P0595364
- P0595365
- P0595366
- P0595367
- P0595368
- P0595369
- P0595370
- P0595371
- P0595372
- P0595373
Distribution
Distributed in 7 states:
- CA
- IL
- NV
- NY
- PA
- SD
- TN
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