Class 2 Device Recall ProxiDiagnost N90 / Precision CRF (706110, 706400

• Date Initiated by Firm: October 01, 2025
• Date Posted: November 07, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0463-2026
• Recall Event ID: 97748
• 510(K)Number: K233945
• Product Classification: System, x-ray, fluoroscopic, image-intensified - Product Code JAA
• Product: Precision CRF; Model Number: 706400
• Code Information: Model Number: 706400; UDI-DI: 00884838110588; Serial Number: 19, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 10001178, 10001179, 10001181, 10001182, 10001184, 10001185, 10001186, 10001187, 10001188, 10001189, 10001190, 10001191, 10001192, 10001193, 10001194, 10001195, 10001196, 10001197, 10001199, 10001200, 10001201, 10001202, 10001203, 10001204, 10001205, 10001206, 10001208, 10001209
• Recalling Firm/ Manufacturer: Philips Medical Systems DMC GmbH ; Development And Manufacturing Ctr.; Rontgenstr. 24; Hamburg Germany
• For Additional Information Contact: Customer Care Solution Center; 1-800-7229377
• Manufacturer Reason for Recall: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
• FDA Determined Cause: Device Design
• Action: On October 1, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters dated September 30, 2025, were sent to customers. The letters described the problem, product and actions to be taken. Actions to be taken: It is safe to continue to use the system(s) in accordance with the intended use. It is recommended that customers use the motorized movement option until the technical solution has been implemented. The system may experience motor drive errors if the force for movement exceeds 110N, which restricts the motorized movement. If the motorized movement does not function, customers should contact their local service representative. B. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm. C. Please retain this Urgent Medical Device Correction letter with your system(s) until the solution is installed; ensure the notice is in a place likely to be seen/viewed. 5. Actions planned by Philips to correct the problem. Philips will provide the technical solution details when finalized. This notice has been reported to the appropriate Regulatory Agencies. 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, 8AM 8PM EST, Monday-Friday).
• Quantity in Commerce: 42 units
• Distribution: Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,
• 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 = JAA