Z-2821-2020Class II

Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and...

Name: Z-2821-2020 Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and...
Creator: ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Published: 2020-07-21
License: https://open.fda.gov/license/

ArjoHuntleigh Polska Sp. zo.o. / initiated 2020-07-21 / Terminated / root cause: design

FDA source

ARJOHUNTLEIGH POLSKA Sp. z.o.o. began a recall of 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... on 2020-07-21. FDA classified it as Class II and gives the reason as "Modular Junction Box (MJB) cables can melt and affect the bed functionality". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2821-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-21
Posted: 2020-08-18
Terminated: 2021-02-17
Recalling firm: ArjoHuntleigh Polska Sp. zo.o.
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.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: Modular Junction Box (MJB) cables can melt and affect the bed functionality.
Root cause tag: design
FDA root cause: Device Design
Action: On July 21st 2020 the firm, ARJO, sent an "URGENT-FIELD SAFETY NOTICE" notification to their US customers indicating the following: Although the likelihood of a serious injury is limited, (as the specific sequence of events is necessary), Arjo is taking this matter very seriously and intends to perform corrective action on the affected units. Next Steps 1. Verify whether you possess devices within the range of this Notice and ensure that all caregivers and users of Arjo Citadel Plus beds are made aware of this Field Safety Notice (FSN). If you do not use Skin IQ mattress, check the position of the Skin IQ cable (situated at the footend of the bed). In order to mitigate the risk of electric shock occurrence, protect the cable connector against touching, e.g by hiding it under the mattress. If Skin IQ mattress is being used (is connected via cable) no risk of electrick shock is present. 3. Ensure that the device does not stay in use if the malfunction occurs (control panels starts blinking, the functionality of the bed is disturbed, unpleasant smell is emitted), until the repair is performed. 4. Complete and sign the enclosed Customer Response Form and return this form to your local Arjo office; Fax: 1-833-329-2756, email:mailto:[email protected] or mail: Arjo Inc., 2349 W Lake St. #250, Addison IL 60101. Once returned, Arjo will contact the designated facility representative listed on the Customer Response Form to schedule the service visit and repair all affected devices at your facility. In situations where Arjo is already aware of number of impacted units at your location, Arjo will offer immediate repair or swap to avoid any logistical inconvenience to our customers. Note: if your facility has sold or moved affected Citadel Bed, please include the new facilitys information in the Customer Response Form. The notice has been submitted to the Regulatory Agency/National Competent Authority in your country. If you have any furth
Quantity in commerce: 145 units
Distribution: Worldwide distribution: US (nationwide) to states of:: FL, KS, LA and countries of:: Australia, Brazil, Canada, France and Germany.
Product codes and lots: Serial number range: P0597830 to P0610470 Model numbers: FXX21A4A4AKFBB, FXX21A4D3AMFBA, FXX21C4B1AAABB, FXX21C4B4ABQBA, FXX21A4C4ACGBB, FXX21A4A1ABUBA, FXX21A6C2ABPBB, FXX21C4B1AAABA, FX811B3B4AMABB, FXX21C4D4AKBBB, FX611A2B2ALVBB

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2821-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2821-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-18

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)