The Recall Desk
HighFDA (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.

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 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
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 →

Related recalls

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

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Same hazard · unintended movement

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