FDA recall Z-2588-2021

ARJOHUNTLEIGH POLSKA Sp. z.o.o. · Class II · device

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.

Distribution

US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA, and SD.

Key facts

Status
Terminated
Initiation date
2021-06-10
Report date
2021-10-06
Termination date
2026-02-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Komorniki, N/A, Poland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2588-2021