The FDA says the updates address customer feedback to enhance the performance of a mechanical ventilator.
Thumbnail courtesy of the FDA [Public domain], via Wikimedia Commons. Above image has been resized courtesy of quinn.anya.
The Puritan Bennett 980 ventilator has been voluntary recalled by Medtronic due to a software update, according to the U.S. Food and Drug Administration (FDA).
The medical device company Medtronic initiated field action yesterday with a software update to address customer feedback — not due to a cybersecurity issue. The software updates the external USB drive performance and its impact on graphical user interface functionality and its labeling displayed during use. Additional product enhancements will also be provided with the update.
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While Medtronic has voluntarily recalled the product, the company told its customers they can continue to use their ventilators before the software update is installed.
The mechanical ventilator is a prescription device operated by trained professionals in an acute or critical care clinical setting used to support a patient’s breathing.
The FDA has classified this as a Class I recall, the most serious of its kind, though Medtronic has not received confirmed reports of serious health consequences related to the issues the software update addresses.
This is not the first time this product was recalled.
In 2015, the ventilator was recalled due to a software error that could affect the amount of air being delivered to the patient. This was a Class I recall because if patients using the ventilator did not receive enough oxygen, it could have resulted in possible injury or death. A software update was implemented to correct the issue. Then in 2016, there was a Class II recall on the product to address issues with the graphical user interface and a field corrective action notice was issued for the ventilator.
The recall once again highlights the increasingly important role that software plays in medical devices. But serious recalls are often related to software vulnerabilities that could jeopardize patient data or safety via cyberattack.
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