| | Class 2 Device Recall Incisive CT |  |
| Date Initiated by Firm | October 29, 2025 |
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| Date Posted | December 03, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0882-2026 |
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| Recall Event ID |
97919 |
| 510(K)Number | K232491 |
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| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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| Product | CT 5300;
Software Version Number: 4.5, 5.0, 5.1; |
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| Code Information |
1) Model Number: 728285;
UDI-DI: 00884838113237;
Serial Numbers: 35071, 800007, 800002, 800001, 800004, 800003;
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Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
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Manufacturer 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | On October 23, 2025 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Please continue to use your system in accordance with its intended use and do not stay in the scan room when scanning.
2. Circulate this URGENT Medical Device Correction letter to all users of this device so that they are aware of the issue.
3. Place this URGENT Medical Device Correction with your system documentation and ensure the letter is in a place likely to be seen/viewed.
4. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the URGENT Medical Device Correction letter, understanding of the issue, and required actions to be taken. Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect the tube heat exchanger screws and correct the loosen screw if necessary (reference FCO72800842).
Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further information or support concerning this issue, please contact your local Philips Customer Care Solutions center: For North America, contact the Customer Care Solutions Center {1-800-722-9377, 8AM - 8PM EST, Monday-Friday). |
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| Quantity in Commerce | 6 units (OUS only) |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = JAK
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