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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

ARJOHUNTLEIGH POLSKA Sp. z.o.o.: Arjo Medical Beds with IndiGo Drive Modules Recalled for Unintended Movement

Agency Publication Date: December 22, 2023
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Summary

Arjo has recalled 929 medical beds, including Enterprise 5000X, 8000X, 9000X, and Citadel models, because the wheels can move unintentionally. These beds are equipped with or have been retrofitted with the IndiGo Drive Assistance module, which is the component causing the unexpected motion. Consumers should verify if their bed is affected by checking the specific serial numbers associated with this voluntary recall.

Risk

The bed wheels may move without user input, which can lead to instability. This poses a risk of falls or collisions for patients and healthcare providers, potentially resulting in injuries during patient transfers or while the bed is stationary.

What You Should Do

  1. Locate the serial number on your Arjo medical bed (Models Enterprise 5000X, 8000X, 9000X, or Citadel) to see if it matches the affected list, which includes over 900 specific identifiers such as P0504690, P0510813, P0595355, and P0493376.
  2. Identify if your bed is equipped with the IndiGo Drive Assistance module or has been retrofitted with one, as only these units are part of the recall.
  3. Contact your healthcare provider or Arjo directly to report any issues and to receive instructions on the necessary corrective actions for your specific unit.
  4. If you are a facility manager, ensure that affected beds are marked for inspection and follow the manufacturer's guidance provided in the notification letter.
  5. For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit the FDA website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer corrective action and medical provider consultation

How to: Contact your healthcare provider or the manufacturer (Arjo) for further instructions regarding the inspection or repair of the IndiGo Drive module and potential refund information.

Affected Products

Product: Arjo Medical Beds (Models Enterprise 5000X, 8000X, 9000X and Citadel) with IndiGo Drive Assistance
Model / REF:
Enterprise 5000X
Enterprise 8000X
Enterprise 9000X
Citadel
UPC Codes:
0505609734548
050560973512
Lot Numbers (929):
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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93463
Status: Active
Manufacturer: ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Sold By: Authorized Arjo distributors; Medical equipment providers
Manufactured In: Poland
Units Affected: 2 products (83 units; 846 units)
Distributed To: Tennessee, California, New York, Illinois, Nevada, Pennsylvania, South Dakota

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.