FDA-Device2021-10-06Class II
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.
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Hazard
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.
Sold states
US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA, and SD.
Affected count
367 units
Manufactured in
Ul. Ks. Piotra Wawrzyniaka 2, N/A, Komorniki, N/A, Poland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2588-2021Don't want to check this manually?
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