FDA DeviceDec 10, 2025Class II

CT 5300; Software Version Number: 4.5, 5.0, 5.1;

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.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

The agency's notice has the remedy and who to contact.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Sold in: Nationwide
Made for: All ages (under 100 years)

This recall covers 2 products — see all of them.

Details

Units affected: 6 units (OUS only)
Illnesses reported: None reported
Manufactured in: 222 Jacobs St, Cambridge, MA, United States
Classification: Class II
Recall number: Z-0882-2026

In the FDA's words

Description: CT 5300; Software Version Number: 4.5, 5.0, 5.1; 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. 1) Model Number: 728285; UDI-DI: 00884838113237; Serial Numbers: 35071, 800007, 800002, 800001, 800004, 800003; Distribution: 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 quantity: 6 units (OUS only)
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.

2 products in this recall

Philips Incisive CT scanners recalled for loose component risk

Philips is recalling two CT scanner models, the Incisive CT and CT 5300, covering 2,347 units. The tube heat exchanger screws may not be tightened properly after a replacement, so the part could detach and contact other components during scanner rotation, possibly damaging them. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
Z-0881-2026 · 2341 units
CT 5300; Software Version Number: 4.5, 5.0, 5.1; (this page)
Z-0882-2026 · 6 units (OUS only)