May 2, 2022

The FDA took the historically unprecedented step of issuing a 518(b) notice, proposing a requirement for Philip to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices. In the notice, the FDA said there is sufficient evidence to determine “that the risk associated with the devices was not caused by the failure of a person other than Philips to exercise due care in the installation, maintenance, repair, or use of the devices at issue.” The agency also stated, “Evidence indicates that the unreasonable risk associated with the products was not caused by the use of ozone cleaning agents, nor did the use of ozone to clean the products constitute a failure to exercise due care.”