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.
FDA Recall Z-2588-2021 · Posted None
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Recalling FirmARJOHUNTLEIGH POLSKA Sp. z.o.o.
Recall StatusTerminated
Product CodeFNL
Date Initiated2021-06-10
Date Terminated2026-02-03
Product Quantity367 units
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA, and SD.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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