Recall Z-2821-2020 ยท FNL Bed, Ac-Powered Adjustable Hospital
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
| Date | Jul 21, 2020 |
| Status | Terminated |
| Reason | Modular Junction Box (MJB) cables can melt and affect the bed functionality. |
| Root cause | Device Design |
| Action | On July 21st 2020 the firm, ARJO, sent an "URGENT-FIELD SAFETY NOTICE" notification to their US customers indicating the following: Although the likelihood of a serious injury is limited, (as the specific sequence of events is necessary), Arjo is taking this matter very seriously and intends to perform corrective action on the affected units. Next Steps 1. Verify whether you possess devices within the range of this Notice and ensure that all caregivers and users of Arjo Citadel Plus beds are made aware of this Field Safety Notice (FSN). If you do not use Skin IQ mattress, check the positio |
| Quantity | 145 units |
| Distribution | Worldwide distribution: US (nationwide) to states of:: FL, KS, LA and countries of:: Australia, Brazil, Canada, France and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.