FDA Expands Draeger's Ventillator Recall to Include Power Supply Batteries
The FDA today said it expanded its recall of Draeger Medical‘s Evita V500 and Babylog VN500 ventilators to include the optional PS500 batteries after they were updated with new power supply firmware that failed to correct the issue depleting the battery.
The original recall, initiated last September and updated in December, put the ventilators on Class I recall status due to an an error with the ventilators in which the battery does not last as long as expected, according to the FDA. The battery indicator light on the units show as sufficiently charged even when the battery is depleted, the agency said.
The original recall, initiated last September and updated in December, put the ventilators on Class I recall status due to an an error with the ventilators in which the battery does not last as long as expected, according to the FDA. The battery indicator light on the units show as sufficiently charged even when the battery is depleted, the agency said.