The Recall Desk
SevereFDA (Devices)·Z-2821-2020·Announced 2020-08-26

Arjo Huntleigh Recalls Citadel Plus Bariatric Bed Frames Due to Melting Cables

Arjo Huntleigh is recalling 145 Citadel Plus Bariatric Bed Frame Systems because Modular Junction Box cables can melt, potentially affecting bed functionality.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves cables melting, which is a structural/electrical defect in a medical device that poses a risk of harm, fitting the criteria for a Severe rating (FDA Class II with potential for significant injury or property damage).

Plain-English summary

Arjo Huntleigh Polska Sp. z.o.o. is recalling 145 units of the Citadel Plus Bariatric Bed Frame System. The recall is due to a defect where Modular Junction Box (MJB) cables can melt, which may affect the functionality of the bed.

The affected bed frames are intended for use in acute and post-acute care environments and are not intended for home care. The recall covers units distributed worldwide, including the United States (specifically Florida, Kansas, and Louisiana), Australia, Brazil, Canada, France, and Germany.

Healthcare facilities should identify affected units by checking the serial number range (P0597830 to P0610470) and model numbers listed in the recall notice. Facilities should contact the manufacturer for instructions on how to proceed with the recall.

The recalled product

Product
Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
Affected units
145

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 (11)

  • Serial number range: P0597830 to P0610470 Model numbers: FXX21A4A4AKFBB
  • FXX21A4D3AMFBA
  • FXX21C4B1AAABB
  • FXX21C4B4ABQBA
  • FXX21A4C4ACGBB
  • FXX21A4A1ABUBA
  • FXX21A6C2ABPBB
  • FXX21C4B1AAABA
  • FX811B3B4AMABB
  • FXX21C4D4AKBBB
  • FX611A2B2ALVBB

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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

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