USA- Philips and the U.S. Department of Justice (DOJ) have agreed to a US$4.2 million settlement for the IntelliVue MP2 Mobile Patient Monitor in accordance with the False Claims Act.
Philips sold MP2s to the U.S. Air Force, U.S. Army, U.S. Navy, and the Defense Logistics Agency between January 1, 2012, and November 27, 2018.
These organizations demand that medical equipment used in specific aircraft environments undergo airworthiness and safe-to-fly testing and certification.
The DOJ said that Philips replaced important parts of the gadget before selling it to military customers without re-certifying it to guarantee it was safe for use in airplanes.
The Dutch multinational admitted that it did not appropriately notify the relevant military certifying facilities in order to establish if the device adjustments would or would not necessitate retesting to preserve airworthiness and safe-to-fly certifications
The business claimed that a provision for the payment had already been recorded.
Philips declared in April 2020 that the FDA has eliminated the manufacturing restrictions imposed as part of a 2017 consent decree on the company’s emergency care and resuscitation division.
Philips is nearing the completion of negotiations with the DOJ on two other settlements.
The discussions are unrelated to the ongoing recall of ventilators and sleep apnea equipment; instead, they are about its Connected Care portfolio.
Roy Jakobs, chief business leader for Philips’ Connected Care unit, said the company received a proposed consent decree from the DOJ on July 18.
The DOJ subpoenaed Philips earlier this year, seeking information about the recall.
In relation to the sleep apnea recall, Philips stated in July that it was in talks with the DOJ for a consent decree.
Philips declared in April 2020 that the FDA has eliminated the manufacturing restrictions imposed as part of a 2017 consent decree on the company’s emergency care and resuscitation division.
It was issued after authorities discovered problems at manufacturing facilities in Massachusetts and Washington and “addressed quality issues with specific components of Philips defibrillators”
Philips had suspended the manufacture and distribution of external defibrillators manufactured at their facilities until they received approval from the FDA.
The decree however allowed Philips to continue the manufacture and distribution of certain automated external defibrillator (AED) models, service ECR devices, and other relevant accessories.
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