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Friday, July 10, 2009
Class I Recall for Respironics' BiPAP Focus Non-Invasive Ventilator System
The FDA yesterday elevated the recall on the BiPAP Focus Non-Invasive Ventilator System to a Class I status. The ventilator, manufactured by Respironics California, Inc., is being recalled for power supply failures. The device is used by healthcare professionals to treat adult patients who have advanced lung disease or difficulty breathing. In the ventilator, a wiring problem may cause a power surge which can exceed the power supply capacity, causing the power supply to lose power and the ventilator to not function properly.
Class I recalls are the most serious type of recall and involve products that the use of can cause serious injury or death. The particular product being recalled is model number PCM120PS18-2315P. Customers or health care providers can contact Respironics Customer Service at 1-877-387-3377.
For more information, see the MedWatch safety information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171242.htm
See the Recall Notice from the FDA at:
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm171194.htm
Class I recalls are the most serious type of recall and involve products that the use of can cause serious injury or death. The particular product being recalled is model number PCM120PS18-2315P. Customers or health care providers can contact Respironics Customer Service at 1-877-387-3377.
For more information, see the MedWatch safety information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171242.htm
See the Recall Notice from the FDA at:
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm171194.htm
Labels: Class 1 recall, FDA, Lung disease, Respironics, Ventilator
posted by
Colleen
at
7:35 AM
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