ARJOHUNTLEIGH POLSKA Sp. z.o.o.: Medical Device Recall in 2021 - (Recall #: Z-2588-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: June 10, 2021

Date Posted: October 6, 2021

Recall Number: Z-2588-2021

Event ID: 88469

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.

Status: Terminated

Product Quantity: 367 units

Code Information:

Manufacturing dates 5/25/2018-2/15/2021 (printed on both the bed and IndiGo module if the module was assembled on the bed at the time of manufacture, or printed on the module if it was later installed on the bed.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated