Bed, Air Fluidized
FDA adverse event reports and recall history for bed, air fluidized (product code INX), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,454
- Deaths
- 33
- Injuries
- 161
- Malfunctions
- 1,158
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2012-03-01TerminatedNonconforming Material/Component
Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized Therapy Unit provides a pressure-relieving sleep surface for patients in the home environment. It helps enable patients with pressure sores to heal their wounds
The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed outer rail, which is extruded Aluminum tubing, is intended to be one piece joined together by a weld at the lower center. The parts receiv
- 2012-03-01TerminatedNonconforming Material/Component
Clinitron Rite Hite Bed headboard and foot side rails. The Clinitron Rite Hite Air Fluidized Therapy Unit is a patient management system that combines air fluidized therapy and low airloss therapy technologies together on a low-height frame. The lower body section provides air fluidized therapy, and the upper body section provides low airloss therapy.
The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed outer rail, which is extruded Aluminum tubing, is intended to be one piece joined together by a weld at the lower center. The parts receiv
- 2009-08-25TerminatedEquipment maintenance
CLINITRON CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.
Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
- 2009-08-25TerminatedEquipment maintenance
CLINITRON UP-LIFT" Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.
Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
- 2004-07-20TerminatedOther
KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080
Battery outgassing of powered hospital beds
- 2003-10-24TerminatedOther
Clinitron At Home Air Fluidized Therapy Unit
Power cord overheating
- 2003-07-10TerminatedOther
CLINITRON CII Air Fluidized Therapy unit.
Malfunction of side-rail latching pin coupled with inadequate directions for use.
- 2003-07-10TerminatedOther
CLINITRON UP-LIFT Air Fluidized Therapy unit.
Malfunction of side-rail latching pin coupled with inadequate directions for use.
- 2003-04-10TerminatedOther
TransportAir, Accessory to an Air Bed, Auxiliary Blower Unit, manufactured by Kinetic Concepts, Inc.
Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge.
Monitor bed, air fluidized automatically
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