Class I designations, the FDA’s most serious classification, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The Puritan Bennett 980 is a mechanical ventilator intended for prescription use by trained professionals to support patient breathing, the Fridley, Minn.-based company said.
The software patch is intended to update the external USB drive performance and its impact on graphical user interface functionality, as well as the labeling displayed on the GUI during ventilator use. The update also includes product enhancements, Medtronic said.
Medtronic said that it also updated the PB980 operators manual with additional information, according to a press release.
The company said that the devices are still safe to use without the update, and that it has not received any confirmed reports of serious adverse health consequences related to the issue the patch is intended to address.
Also this week, Medtronic said that it agreed to pay $50.9 million to settle a number of U.S. Dept. of Justice probes into marketing activities from companies it acquired, including Covidien and ev3.
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