Arjo Hospital Equipment AB

5 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices, Infusion Pumps

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.

Class I - Dangerous

The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.

Sep 1, 2014 Other Medical Devices Nationwide View Details →

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.

Class I - Dangerous

The recalled devices labeling and instructions for use contain unapproved medical claims.

Dec 3, 2014 Infusion Pumps Nationwide View Details →

RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.

Class I - Dangerous

The recalled devices labeling and instructions for use contain unapproved medical claims.

Dec 3, 2014 Infusion Pumps Nationwide View Details →

Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.

Class I - Dangerous

The recalled devices labeling and instructions for use contain unapproved medical claims.

Dec 3, 2014 Other Medical Devices Nationwide View Details →

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.

Class I - Dangerous

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.

Mar 17, 2014 Infusion Pumps Nationwide View Details →