FDA-Device2025-12-10Class IIPROCESSING DEFECT
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Hazard
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Ethiopia, France, FrenchPolynesia, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Moldova, Montenegro, Montserrat, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua Nw Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Rwanda, Saint Kitts, Saint Lucia, Saudi Arabia, Serbia, Sint Maarten (D, Slovakia, South Africa, South Korea, Spain, St.Pier,Miquel., Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.
Affected count
6 units (OUS only)
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0882-2026More Philips recalls
- FDA-Device2026-09-09Philips Brilliance iCT CT scanner recalled for unintended radiation issue
- FDA-Device2026-09-09Philips IQon Spectral CT recalled for unintended radiation issue affecting equipment performance
- FDA-Device2026-09-09Philips Ingenuity CT and related systems recalled for unintended radiation issue
- FDA-Device2026-09-09Philips Brilliance CT 64 systems recalled for unintended radiation issue
- FDA-Device2026-07-01Philips Telemetry Monitor 5500 recalled for potential device reset and loss of central monitoring connection
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