FDA Medical Device Recalls (openFDA)
ARJOHUNTLEIGH POLSKA Sp. z.o.o.: 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 number
- Z-2588-2021
- Recalling firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- 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.
- Status
- Terminated
- Initiated
- 2021-06-10
- Posted
- not on file
- Terminated
- 2026-02-03
- 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.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 367 units
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA, and SD.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNL
- Firm FEI
- 3007420694
- Firm city
- Komorniki
- Firm state
- not on file
- Firm country
- Poland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28