Class 2 Device Recall CombiDiagnost PCF

• Date Initiated by Firm: December 19, 2019
• Date Posted: February 20, 2020
• Recall Status: Terminated on June 18, 2020
• Recall Number: Z-1329-2020
• Recall Event ID: 84773
• 510(K)Number: K163210
• Product Classification: System, x-ray, fluoroscopic, image-intensified - Product Code JAA
• Product: CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
• Code Information: (domestic only) SN374 SN17081704 SN17121782 SN18011800 SN18081862 SN18061846 SN18111907
• Recalling Firm/ Manufacturer: Philips Medical Systems Gmbh, DMC; Development And Manufacturing Ctr.; Rontgenstr. 24; Hamburg Germany
• For Additional Information Contact: Kathy LaBrie; 978-430-8257
• Manufacturer Reason for Recall: When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.
• FDA Determined Cause: Software design
• Action: On December 19, 2019, the firm initiated mailing of the Medical Device Recall Letter to all affected customers. Customers were advised to use the system according to the Instructions for Use (IFU). In particular: Error 80 issue: The issue can be prevented if the operator avoids tilting the table by Table Up/Down joystick and instead uses the Table Tilt Left/Right joystick. If the issue occurs, the operator should remove the patient from the table and bring him/her to upright position so that the contrast agent does not enter the brain. SPDU issue: The user should pay attention to whether it smells of smoke in the room. If this is the case, immediately engage the system emergency stop button on the table or geometry control console, remove patient, stop using the system for further examinations and contact customer service. Philips plans to install a system software version upgrade and to perform an on-site check of the SPDU thermos contact at affected systems, which will eliminate these issues. A Philips Service Engineer will contact you when the Field Action Kit is available to be implemented. Should you need to communicate with Philips with regard to this program, please reference Field Change Order (FCO) 70900045 if you have a CombiDiagnost GCF system and FCO 70900048 if you have a CombiDiagnost PCF system. Technical Support Line: 1-800-722-9377.
• Quantity in Commerce: 131
• Distribution: Worldwide distribution  US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MI, MN, MO, MT, NC, NJ, NY, OH, TX, UT, VA and countries of Canada, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, China, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Dominican Republic, Egypt, Ethiopia, France, Germany, Ghana, Hungary, Iran, Italy, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Nigeria, Oman, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
• 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