Class 2 Device Recall Spectral CT 7500

• Date Initiated by Firm: March 17, 2023
• Date Posted: May 12, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1584-2023
• Recall Event ID: 92064
• 510(K)Number: K203020
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
• Code Information: UDI-DI: 00884838101111; Serial Numbers: 10058 10074 10080 10093 10096 10097 10098 10099 10100 10102 10103 10104 10105 10106 10107 10109 10110 10111 10114 10115 10117 10119 10123 396001 396003 10014 10015 10016 10017 10018 10019 10020 10021 10022 10023 10024 10025 10027 10031 10032 10033 10034 10035 10036 10038 10039 10040 10041 10042 10043 10044 10045 10046 10047 10048 10050 10051 10052 10053 10055 10056 10057 10059 10060 10061 10062 10063 10065 10066 10067 10068 10069 10070 10075 10076 10077 10081 10082 10085 10086 10087 10089 10090 10092 10094 10095 10108 10116 10120 10049 10121 10124
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• Manufacturer Reason for Recall: Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT Medical Device Correction notification letter dated 3/17/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users Immediately stop using the Unload Pedal of the Foot Switch until Philips installs a solution on your system. Instead of using the Unload Pedal, please use the Unload Patient function on the Gantry Control Panels, or use other Table In/Out, Up/Down functions on the Gantry Control Panels, CT Scan Control Box, or Hardware Interventional Controls to fulfill the normal patient unloading function, as instructed in the IFU. You may continue to use Load Pedal, and Free-Float Pedal of Foot Switch, as they are not affected by this Urgent Medical Device Correction Letter. 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. 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 a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. Actions planned by Philips to correct the problem Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the solution to resolve this issue (refer to FCO72800795). 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 representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).
• Quantity in Commerce: 92 units
• Distribution: Worldwide - US Nationwide distribution including in the states of States: AZ, IN, MA, MD, MN, NY, OH, PA, and TX. The countries of Australia, Austria, China, Czech Republic, Denmark, France, Germany, Israel, Japan, Malaysia, Netherlands, Norway, Palestine, Panama, South Korea, Spain, Switzerland, Thailand, United Kingdom.
• 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