Arjo Hospital Equipment Ab
FDA adverse event reports naming Arjo Hospital Equipment Ab as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ARJO HOSPITAL EQUIPMENT AB.
- Total reports
- 1,447
- Deaths
- 53
- Injuries
- 364
- Malfunctions
- 892
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.
Top device categories
Recent recalls
- 2015-03-06TerminatedDevice Design
Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
- 2015-02-27TerminatedLabeling design
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
The recalled devices labeling and instructions for use contain unapproved medical claims.
- 2015-02-27TerminatedLabeling design
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
The recalled devices labeling and instructions for use contain unapproved medical claims.
- 2015-02-27TerminatedLabeling design
TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
The recalled devices labeling and instructions for use contain unapproved medical claims.
- 2014-10-06TerminatedLabeling design
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40.
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