CT 5300 recall
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Why was CT 5300 recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) Model Number: 728285; UDI-DI: 00884838113237; Serial Numbers: 35071, 800007, 800002, 800001, 800004, 800003;
- Product
- CT 5300; Software Version Number: 4.5, 5.0, 5.1;
- Recalling firm
- Philips North America Llc
- Quantity
- 6 units (OUS only)
- 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.
- Recall date
- December 10, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)