Recall Z-2588-2021— ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Class II · Terminated
Class II FDA medical device recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., initiated 2021-06-10, terminated 2026-02-03. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-10
- Terminated
- 2026-02-03
- Firm location
- Komorniki, N/A, Poland
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.