Data Foundry

Medical device recalls 2021

Arjo Citadel beds originally assembled with the IndiGo modules during… — Class II medical device recall Z-2588-2021

Terminated recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., reported 2021-10-06, distributed nationwide. The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, b

Recall numberZ-2588-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmARJOHUNTLEIGH POLSKA Sp. z.o.o., Komorniki, N/A, Poland
Recall initiated2021-06-10
Classified2021-09-29
Reported by FDA2021-10-06
Terminated2026-02-03
DistributedNationwide (US)
Quantity367 units
Reason classesdevice malfunction
Model numbersCX812A3J3AMAD0

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2588-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.