August 30, 2022

Medical device manufacturer Philips North America has agreed to pay $4.2 million to resolve allegations that it violated the False Claims Act by falsely certifying that mobile patient monitoring devices it sold to military purchasers met standards for airworthiness and passed safe-to-fly testing required to ensure that medical devices can safely be used in aircraft.  As part of the settlement, Philips admitted that after receiving initial approval in 2008, it made modifications to the device but did not inform government purchasers of those modifications, so that a determination could be made if re-testing was required.  USAO MA

Tagged in: Certifications, FCA Federal, Government Procurement Fraud, Healthcare Fraud, Medical Devices and DME,