FDA Device Info: Records Regarding Philips Recalled Devices

All records relating to the 510(k) clearance of Philips recalled devices, including any recent amended applications seeking to "remediate" (i.e. repair and replace) the recalled devices, as well as any analyses performed by FDA or Philips and any information relating to FDA's decision to upgrade the recall from Class II to Class I. [REQ YEAR: 2021]