Z-2588-2021 Class II Terminated
FDA device recall Z-2588-2021 was initiated by ARJOHUNTLEIGH POLSKA Sp. z.o.o. on June 10, 2021 and is designated Class II. 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. The recall status is terminated (terminated February 3, 2026). Affected quantity: 367 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- June 10, 2021
- Termination Date
- February 3, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 367 units
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.
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 Pattern
US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA, and SD.
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.