Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of PhilipsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Philips Headquarters Cambridge with 4 device recalls. The most recent is a device recall dated Apr 12, 2023: Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 12, 2023 | Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144Class II · Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect | Device recalls |
| Apr 12, 2023 | Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)Class II · Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect | Device recalls |
| Apr 12, 2023 | Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)Class II · Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect | Device recalls |
| Apr 12, 2023 | Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)Class II · Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built