Z-2588-2021Class II

Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number...

Name: Z-2588-2021 Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number...
Creator: ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Published: 2021-06-10
License: https://open.fda.gov/license/

ArjoHuntleigh Polska Sp. zo.o. / initiated 2021-06-10 / Terminated / root cause: manufacturing process

FDA source

ARJOHUNTLEIGH POLSKA Sp. z.o.o. began a recall of Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be... on 2021-06-10. FDA classified it as Class II and gives the reason as "The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emission of sparks". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2588-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-10
Posted: 2021-09-29
Terminated: 2026-02-03
Recalling firm: ArjoHuntleigh Polska Sp. zo.o.
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 assembled at the time of manufacturing and subsequently retrofitted on the beds.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emission of sparks.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The Field Safety Notice dated 6/9/2021 was issued in two different mailings, one on 6/10/2021 and the second on 6/18/2021. The letter explained the issue and provided instructions for use until the product is corrected by Arjo personnel. All caregivers and users of the bed with IndiGo were to be made aware of the Field Safety Notice. A Customer Response Form was enclosed for completion to indicate the number of beds currently listed at the facility and that the customer has read and understands the Field Safety Notice. If the bed has been sold or moved, the customer is to provide information on the new facility.
Quantity in commerce: 367 units
Distribution: US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA, and SD.
Product codes and lots: Manufacturing dates 5/25/2018-2/15/2021 (printed on both the bed and IndiGo module if the module was assembled on the bed at the time of manufacture, or printed on the module if it was later installed on the bed.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2588-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2588-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-29

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)