FDA-Device2025-10-01Class II
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
Hazard
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Sold states
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.
Affected count
24 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2602-2025More Philips North America Llc recalls
- FDA-Device2026-07-01Philips Telemetry Monitor 5500 recalled for potential device reset and loss of central monitoring connection
- FDA-Device2026-07-01Philips Avalon Fetal Monitor FM 30 recalled for speaker connector assembly defect
- FDA-Device2026-07-01Philips Avalon FM20 Fetal Monitor recalled for speaker connector assembly defect
- FDA-Device2026-06-17Philips DigitalDiagnost C90 Flex/Value/Chest/ER recalled for missing seismic stabilization kit
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