Agency classClass IIOur severity:High FDA (Devices)·Z-2588-2021·Announced 2021-10-06

Arjo Citadel Beds: Power Cord Wear May Cause Electrical Hazard

Certain Arjo Citadel medical beds with IndiGo power cords may develop wear during normal use, potentially causing electrical short circuits and fire hazards. Units manufactured from May 2018 through February 2021 are affected.

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 with no reported injuries or illnesses. The hazard is theoretical—potential electrical short circuits and fire risks from cord wear—with no confirmed incidents. Per the rubric, risk-of-harm products with no reported injuries score at most 3 (High).

Plain-English summary

Arjo is recalling Citadel medical beds originally assembled with IndiGo power modules and IndiGo retrofit modules that can be installed on Citadel or Enterprise beds. The recall involves 367 units manufactured between May 25, 2018, and February 15, 2021.

The IndiGo power cord may wear during normal use, potentially leading to damage. A worn cord can result in cuts, burns, or short circuits with limited spark emission, creating risks of electrical shock and fire.

Affected units were distributed nationwide to California, Florida, Illinois, Kentucky, Maryland, Nevada, New York, Pennsylvania, and South Dakota. Consumers should stop using these beds immediately and contact Arjo for repair or replacement instructions.

This is a Class II recall. Consumers with questions should contact the manufacturer for guidance on inspection, repair, or replacement options.

The recalled product

Product: Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules…
Manufacturer: ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Category: Medical Device — Hospital Bed
Hazard: short-circuit
fire-hazard
electrical-shock
Affected units: 367

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 (1)

or printed on the module if it was later installed on the bed.

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

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

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Same hazard · short circuit