A class I product recall has been issued by the FDA for the Puritan Bennett 840 Series Ventilator manufactured by Covidien. A software problem may cause the Ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. This medical device is usually used on critically ill patients who may not be able to breathe without the ventilator. Therefore if the ventilator inadvertently stops the patient may suffer serious personal injury or death.
Read the complete FDA safety Alert