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Recall Observatory FDA recall evidence

Device 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.

Z-2821-2020

July 21, 2020

Class II

Product summary

Firm
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Event
Event 86065
Status
Terminated
Classification
Class II
Quantity
145 units
Official record key
device-enforcement:Z-2821-2020

Official wording

Reason: Modular Junction Box (MJB) cables can melt and affect the bed functionality.

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

Distribution pattern: Worldwide distribution: US (nationwide) to states of:: FL, KS, LA and countries of:: Australia, Brazil, Canada, France and Germany.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Modular Junction Box (MJB) cables can melt and affect the bed functionality.