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CareFusion 203 Recalls
2 recalls on record · July 25, 2012 to October 1, 2014 · Medical Devices
Recalls by year
12
14
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 1, 2014Medical DevicesFDA
CareFusion 203, Inc. recalls CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respira
Hazard: CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and pre
July 25, 2012Medical DevicesFDA
CareFusion 203, Inc. recalls CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and
Hazard: CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP or Patient Circuit Fault Alarm both audibly and Visually to alert the healthcare professional. Ventilation delivery to the patient may be compromised.