Z-0611-2024Class II

Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with...

Name: Z-0611-2024 Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with...
Creator: ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Published: 2023-08-29
License: https://open.fda.gov/license/

ArjoHuntleigh Polska Sp. zo.o. / initiated 2023-08-29 / Open, Classified / root cause: design

FDA source

ARJOHUNTLEIGH POLSKA Sp. z.o.o. began a recall of Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with... on 2023-08-29. FDA classified it as Class II and gives the reason as "Unintended movement of bed wheels". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0611-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-29
Posted: 2023-12-22
Recalling firm: ArjoHuntleigh Polska Sp. zo.o.
Product: Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: Unintended movement of bed wheels
Root cause tag: design
FDA root cause: Device Design
Action: Arjo issued an URGENT MEDICAL DEVICE RECALL NOTICE to its consignees on 08/29/2023 via US mail. The notice explained the problem with the device and provided instructions for risk mitigation until a permanent technical solution to the issue is available.
Quantity in commerce: 83 units
Distribution: US: TN, CA, NY, IL, NV, PA, SD
Product codes and lots: UDI/DI 0505609734548, serial numbers: P0504690, P0504691, P0510813, P0512547, P0512548, P0515453, P0515454, P0515455, P0515456, P0515457, P0516242, P0517649, P0517650, P0517651, P0517652, P0517653, P0517654, P0517655, P0517656, P0517657, P0517658, P0519068, P0525670, P0525671, P0525672, P0525673, P0525674, P0525675, P0525676, P0525677, P0525678, P0525679, P0525680, P0525681, P0525682, P0525683, P0525684, P0525685, P0525686, P0526405, P0526406, P0526407, P0526408, P0526409, P0526410, P0526425, P0526426, P0526427, P0526428, P0526429, P0526430, P0526431, P0526432, P0527297, P0527298, P0527299, P0527300, P0527301, P0527302, P0529533, P0529534, P0529535, P0529536, P0494034, P0494035, P0494036, P0494037, P0494038, P0494039, P0494040, P0494041, P0494042, P0494043, P0494044, P0494045, P0494046, P0494047, P0494048, P0501255, P0501256, P0501257, P0501258, P0501259

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0611-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0611-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-03	2023-12-22
Z-0612-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-03	2023-12-22

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)