CitadelRecalls & reported problems across all models
Arjohuntleigh AB · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 135
- Deaths reported
- 3
- Injuries reported
- 17
- Recalls
- 0
We found 3 models of Citadel by Arjohuntleigh AB in the FDA's device registry (GUDID). Together they are named in 135 adverse event reports in the FDA's MAUDE database, received between May 23, 2018 and Sep 21, 2026 — classified as 3 deaths, 17 injuries, 115 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (38 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Citadel problems
Device problems
- Unintended Movement38
- Use of Device Problem36
- Detachment of Device or Device Component32
- Insufficient Device Problem Information11
- Adverse Event Without Identified Device or Use Problem7
- Sparking5
- Mechanical Problem4
- Activation Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- Fall41
- No Consequences Or Impact To Patient12
- No Patient Involvement4
- Pressure Sore/Ulcer4
- Ulcer4
- Bruise/Contusion3
- Convulsion/Seizure3
Citadel models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Citadel CX811A3F3AMAB0BED, FLOTATION THERAPY, POWERED1 death125 reports
- Citadel CX611B3F4AMAB0BED, FLOTATION THERAPY, POWERED2 deaths9 reports
- Citadel CX812A3K1AMAD0BED, FLOTATION THERAPY, POWERED1 report
Recent Citadel adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Use of Device Problem
According to the information provided by the customer, the patient fell from the bed and the patient was not aware of what was going on. The customer also indicated that a side rail was down and that the VariZone patient movement/exit detection system did not generate an alarm. No injury was reported.Technical evaluation of the bed was performed. The customer-reported alarm failure could not be reproduced. Functional testing confirmed that the side rails and the VariZone patient movement/exit detection system operated as intended, and no device malfunction that could have contributed to the reported fall was identified. Upon delivery of the replacement bed, the service representative provided instructions regarding the proper use of the bed sensory alarm.
Patient problems: Fall
MAUDE report 50835218 ↗MalfunctionSep 10, 2026Unintended Movement
At the time of the inspection of the Citadel bed frame returned from the customer, an Arjo service technician found that the button responsible for the backrest upward movement, located on the attendant control panel (ACP) on the right-hand foot-end side rail, was stuck in the activated position. There was no patient involvement, and no injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50708357 ↗MalfunctionAug 14, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50248101 ↗InjuryJul 29, 2026Failure to Run on Battery
The patient experienced a seizure, followed by respiratory arrest and the Citadel bed did not perform as intended for a code blue. It was stated the battery died and the patient had an emergency intubation and was transferred to ICU. According to the Arjo Clinical Specilist the patient's intubation and transfer to ICU does meet the definition of a serious injury.Additionally, as a result of this event, the caregiver had to support the patient's position to maintain the patient's airway, which caused the caregiver to injure their back. However, there was no indication that the caregiver's back injury was serious.
Patient problems: Convulsion/Seizure; Respiratory Arrest
MAUDE report 50065932 ↗InjuryJul 29, 2026Failure to Run on Battery
The patient experienced a seizure, followed by respiratory arrest and the Citadel bed did not perform as intended for a code blue. It was stated the battery died and the patient had an emergency intubation and was transferred to ICU. According to the Arjo Clinical Specilist the patient's intubation and transfer to ICU does meet the definition of a serious injury.Additionally, as a result of this event, the caregiver had to support the patient's position to maintain the patient's airway, which caused the caregiver to injure their back. However, there was no indication that the caregiver's back injury was serious.
Patient problems: Convulsion/Seizure; Respiratory Arrest
MAUDE report 50065929 ↗MalfunctionJun 25, 2026Unintended Movement
DURING A QUALITY CONTROL INSPECTION PERFORMED AFTER THE CITADEL BED FRAME WAS RETURNED FROM THE CUSTOMER, AN ARJO SERVICE TECHNICIAN OBSERVED THAT THE BED MOVED INTO THE CHAIR POSITION WITHOUT ANY COMMAND BEING GIVEN. THERE WAS NO PATIENT INVOLVEMENT. NO INJURY WAS REPORTED. THE LEFT-HAND HEAD-END SAFETY SIDE HAD A DEFECTIVE AUTO-CHAIR BUTTON ON THE CONTROL PANEL. THE ISSUE WAS RESOLVED BY REPLACING THE SIDE RAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25618966 ↗MalfunctionJun 3, 2026Use of Device Problem
ARJO BECAME AWARE THAT THE PATIENT FELL FROM THE CITADEL BED TWICE. NO INJURIES WERE SUSTAINED. REPORT 3007420694-2026-00095 RELATES TO THE FIRST FALL, WHILE REPORT RELATES TO THE SECOND FALL. MOREOVER, THE BIOMED REPRESENTATIVE INFORMED THAT THE BED EXIT ALARM OR NURSE CALL SYSTEM WAS DEFECTIVE. THE DEVICE INSPECTION DID NOT REVEAL ANY MALFUNCTIONS.
Patient problems: Fall
MAUDE report 25371619 ↗MalfunctionMay 26, 2026Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE LEFT-HAND FOOT-END SIDE RAIL OF THE CITADEL BED IS TOTALLY DETACHED. THE ARJO SERVICE TECHNICIAN INSPECTED THE BED AND FOUND THAT THE SCREWS HOLDING THE PANEL TO THE METAL PLATE WERE RIPPED OFF. THE BED WAS LIKELY BEING USED BY A PATIENT. NO INJURY WAS CLAIMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25276522 ↗MalfunctionMay 12, 2026Detachment of Device or Device Component
ARJO BECAME AWARE OF THE CITADEL BED FRAME MALFUNCTION. THE CUSTOMER REPORTED THAT THE "HEAD OF BED WON'T RAISE DUE TO A BROKEN PIECE." THE BED WAS IN USE BY A PATIENT WHEN THE ISSUE OCCURRED. NO INJURY WAS REPORTED. AN INSPECTION CARRIED OUT BY AN ARJO REPRESENTATIVE REVEALED THAT THE SCREW SECURING THE HINGE TO THE FRAME WAS MISSING. THIS FAILURE RESULTED IN THE HINGE DISCONNECTION. ADDITIONALLY, THE BACKREST DAMPER AND THE BACKREST ACTUATOR WERE DAMAGED AND REQUIRED REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25146453 ↗MalfunctionMay 12, 2026Unintended Movement
ARJO BECAME AWARE THAT THE CITADEL PATIENT CARE SYSTEM WAS NOT FUNCTIONING PROPERLY. THE CUSTOMER REPORTED: "FOOT SECTION OF THE BED NOT INFLATING, BUTTONS ARE NOT ON". THE BED WAS IN USE BY A PATIENT AT THE TIME. NO INJURY WAS REPORTED. NO SYSTEM MALFUNCTION WAS IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25146452 ↗MalfunctionApr 17, 2026Use of Device Problem
IT WAS REPORTED THAT THE PATIENT FELL OUT OF BED. NO INJURY WAS SUSTAINED. THE CIRCUMSTANCES OF THE EVENT REMAINED UNKNOWN. THE NURSE CLAIMED THAT AN "EXIT ALARM" WAS ON, BUT DID NOT SOUND AT THE NURSE STATION. IT WAS IDENTIFIED THAT THE NURSE CALL CABLE WAS NOT PROPERLY ATTACHED TO THE HOSPITAL SYSTEM. THE STAFF IS RESPONSIBLE FOR THE CORRECT CONNECTION OF THE NURSE CALL CABLE.
Patient problems: Fall
MAUDE report 24907899 ↗MalfunctionMar 31, 2026Use of Device Problem
IT WAS REPORTED THAT THE PATIENT FELL OUT OF BED. NO INJURY WAS SUSTAINED. THE CUSTOMER INDICATED THAT THE PATIENT WAS TRYING TO GET OUT OF BED. NO INJURY WAS SUSTAINED. THE STAFF CLAIMED THAT AT THE TIME OF THE FALL, THE VARIZONE MOVEMENT SYSTEM WAS ON AND DID NOT SOUND. THE BED WAS SWAPPED TO THE SERVICE CENTER. THE BED EVALUATION WAS PERFORMED, AND THE PATIENT'S MOVEMENT SYSTEM WAS CHECKED; NO MALFUNCTION WAS FOUND.
Patient problems: Fall
MAUDE report 24738966 ↗MalfunctionMar 31, 2026Detachment of Device or Device Component
THE SAFETY SIDE DETACHED FROM THE FRAME. THERE WAS NO PATIENT INVOLVEMENT. NO INJURY WAS CLAIMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24738965 ↗MalfunctionMar 31, 2026Use of Device Problem
IT WAS REPORTED THAT THE PATIENT FELL OUT OF BED. NO INJURY WAS SUSTAINED. THE CUSTOMER INDICATED THAT THE PATIENT WAS TRYING TO GET OUT OF BED. NO INJURY WAS SUSTAINED. THE STAFF CLAIMED THAT AT THE TIME OF THE FALL, THE VARIZONE MOVEMENT SYSTEM WAS ON AND DID NOT SOUND. THE BED WAS SWAPPED TO THE SERVICE CENTER. THE BED EVALUATION WAS PERFORMED, AND THE PATIENT'S MOVEMENT SYSTEM WAS CHECKED; NO MALFUNCTION WAS FOUND.
Patient problems: Fall
MAUDE report 24738949 ↗MalfunctionFeb 4, 2026Sparking
DURING PLUG IN THE BED INTO THE SOCKET, THE BED SPARKED. THERE WAS NO INDICATION OF THE PATIENT'S INVOLVEMENT. NO INJURY WAS CLAIMED. THE ARJO REPRESENTATIVE REPLACED THE POWER CORD, AND THE BED WAS OPERATED AS INTENDED. NO VISUAL SIGNS OF THE POWER CABLE DAMAGES WAS OBSERVED BY THE ARJO REPRESENTATIVE. HOWEVER, TAKING A CONSERVATIVE APPROACH, HE DECIDED TO REPLACE THE BEDS POWER CORD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24256053 ↗
Other Arjohuntleigh AB products
All Arjohuntleigh AB devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page