Agency classClass IIOur severity:High FDA (Devices)·Z-0611-2024·Announced 2024-01-03

Arjo Medical Beds Recalled Due to Unintended Wheel Movement

Arjo medical beds with IndiGo Drive Assistance modules may have wheels that move unintentionally. This recall affects 83 units in seven U.S. states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 is an FDA Class II recall of a medical device with no reported injuries or illnesses. The hazard of unintended bed wheel movement presents a potential risk but has not resulted in documented harm.

Plain-English summary

Arjo medical beds in Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X, and Citadel, assembled with or retrofitted with IndiGo Drive Assistance modules, are the subject of this Class II recall due to unintended movement of the bed wheels.

The recall affects 83 units that were distributed to Tennessee, California, New York, Illinois, Nevada, Pennsylvania, and South Dakota. The affected medical device identifier is UDI/DI 0505609734548.

Users and healthcare facilities should immediately cease use of any bed matching the recalled models and serial numbers. Contact ARJOHUNTLEIGH POLSKA or the FDA for further instructions on replacement or repair.

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 Bed
Hazard: unintended-movement
Affected units: 83

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)

UDI/DI 0505609734548
serial numbers: P0504690
P0504691
P0510813
P0512547
P0512548
P0515453
P0515454
P0515455
P0515456
P0515457
P0516242
P0517649
P0517650
P0517651
P0517652
P0517653
P0517654
P0517655
P0517656

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 2 recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · ARJOHUNTLEIGH POLSKA Sp. z.o.o.

See all →

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Same hazard · unintended movement