Class 2 Device Recall IQon Spectral CT

• Date Initiated by Firm: January 07, 2026
• Date Posted: February 06, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1316-2026
• Recall Event ID: 98248
• 510(K)Number: K193454
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: IQon Spectral CT; Product Code (REF): 728332
• Code Information: Product Code (REF): 728332; UDI-DI: 00884838059542; Serial Numbers: 60128, 60141, 60151, 60161, 60171, 60181, 60129, 60142, 60152, 60162, 60172, 60182, 60130, 60143, 60153, 60163, 60173, 60132, 60144, 60154, 60164, 60174, 60133, 60145, 60155, 60165, 60175, 60134, 60146, 60156, 60166, 60176, 60136, 60147, 60157, 60167, 60177, 60137, 60148, 60158, 60168, 60178, 60138, 60149, 60159, 60169, 60179, 60139, 60150, 60160, 60170, 60180.
• FEI Number: 3016618143
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Philips Customer Care Solutions Center; 800-722-9377
• Manufacturer Reason for Recall: As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
• FDA Determined Cause: Process change control
• Action: On or about January 7, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. As a precaution, monitor the gantry for any unusual sounds or vibrations during operation. If unusual sounds are heard or vibrations are observed, immediately call your service contact. In the absence of unusual sounds or vibrations, you may continue to use your system(s) according to the intended use. 2. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until Philips has inspected your system and has provided any correction, if needed. Ensure the letter is in a place likely to be seen and read. Actions planned by Philips: Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and to inspect the fasteners on your system (reference FCO72800845). If the inspection indicates that your system is affected, Philips will perform the correction to resolve the issue (reference FCO72800846)
• Quantity in Commerce: 52 units
• Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Macao, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkmenistan, United Kingdom, Uzbekistan, Vietnam.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = JAK