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U.S. Department of Health and Human Services

Class 2 Device Recall CombiDiagnostGCF

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 Class 2 Device Recall CombiDiagnostGCFsee related information
Date Initiated by FirmDecember 19, 2019
Date PostedFebruary 20, 2020
Recall Status1 Terminated 3 on June 18, 2020
Recall NumberZ-1328-2020
Recall Event ID 84773
510(K)NumberK163210 
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
ProductCombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Code Information (domestic only) SN18061848 SN17071689 SN18051832 SN190251 SN17111759 SN17111752 SN18011793 10000020 SN17121783 SN17121785 SN18021816 SN18101890 SN19031950 SN17071688 SN18101903 SN17071683 SN17101722 SN17101729 SN17111758 SN17111763 SN17031622 SN17071692 SN17041642 SN18101886 SN18011794 SN19021934 SN19021943 SN17111770 SN18011802 SN19021942 SN17121779 SN17031618 SN17101733 SN17021613 SN17021613 
Recalling Firm/
Manufacturer		 Philips Medical Systems Gmbh, DMC
Development And Manufacturing Ctr.
Rontgenstr. 24
Hamburg Germany
For Additional Information ContactKathy 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 2		Software design
ActionOn 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 Commerce116
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = JAA
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