FDA Recall Terminated

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.

Recall: Z-2588-2021 · Initiated June 10, 2021

Recall

Recall Number
Z-2588-2021
Event Number
88469
Firm
ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ul. Ks. Piotra Wawrzyniaka 2 Komorniki Poland
FEI Number
3007420694
Product Code
FNL
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
June 10, 2021
Terminated
February 3, 2026

Description

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

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.

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.

Distribution

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

Quantity

367 units