Categories

Potential Exposure to Certain Chemicals with Use of GE HealthCare EVair and EVair03 Compressors with Certain Ventilators – Letter to Health Care Providers

FDA issues a letter to health care providers on potential exposure to certain chemicals with use of GE HealthCare EVair and EVair03 compressors with certain ventilators.

http://www.fda.gov/medical-devices/letters-health-care-providers/potential-exposure-certain-chemicals-use-ge-healthcare-evair-and-evair03-compressors-certain

 
Categories

Datex-Ohmeda Recalls EVair Air Compressors Due to Formaldehyde Emissions Found in Specific Conditions When Used with CARESCAPE R860, Engstrom Carestation or Pro Ventilators

EVair Air compressors recalled due to increased formaldehyde emissions at high temperature and low gas flow conditions when used with certain ventilators.

http://www.fda.gov/medical-devices/medical-device-recalls/datex-ohmeda-recalls-evair-air-compressors-due-formaldehyde-emissions-found-specific-conditions-when

 
Categories

Megadyne Reiterates Intended Use Population Change for Megadyne Mega Soft Universal and Universal Plus Patient Return Electrodes

Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA S

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadyne-reiterates-intended-use-population-change-megadyne-mega-soft-universal-and-universal-plus