Philips North America Llc: Device Recall

Recall #Z-0881-2026 · 10/29/2025

Class II: Risk

Recall Details

Recall Number
Z-0881-2026
Classification
Class II
Product Type
Device
Recalling Firm
Philips North America Llc
Status
Ongoing
Date Initiated
10/29/2025
Location
Cambridge, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2341 units

Reason for Recall

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.

Product Description

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

Distribution Pattern

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.

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.