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19,200 Respironics Ventilators Recalled - Software Causing Silent Shut Downs


Respironics California, Inc., a Philips Healthcare business, initiated a worldwide recall of approximately 19,200 Philips Respironics V60 Ventilators to correct a software issue that may cause the V60 ventilator device to shut down. Specifically, the recall was initiated to correct an issue with the V60 Ventilator Power Management (PM) Printed Circuit Board Assembly (PCBA) PlC software that was discovered through routine product monitoring. If the issue were to occur, there is a possibility that the V60 Ventilator could cease functioning during use, resulting in the loss of ventilator support, potentially with no audible alarm from the ventilator.

 

Following review, the FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

The Philips Respironics V60 ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

 

Respironics has notified all United States distributors, providers, sales personnel and customers that may have devices subject to this recall. The PM PCBA PIC software issue has been corrected, and Respironics will update the software on all V60 ventilators shipped from the manufacturer prior to April 1, 2013.

 

See the Recall

 

 

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