Class 2 Device Recall Philips Ingenuity CT

• Date Initiated by Firm: June 24, 2019
• Date Posted: August 06, 2019
• Recall Status: Terminated on October 06, 2022
• Recall Number: Z-2188-2019
• Recall Event ID: 83365
• 510(K)Number: K160743
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Ingenuity Core Model # 728321, computed tomography x-ray system
• Code Information: System Serial Number 10634, 31001, 52000- 52001, 52003- 52004; ; 52006 through 52022 52024- 52027, 52029 through 52073; ; 52075 through 52102, 52104 through 52158, 52160- 52161, 95726, 95738, 95739, 100827, 122416, 200090, 300087, 300095, 300155, 310001- 310002, 310006- 310008, 310009- 310010, 310012 through 310018, 310020 through 310026, 310028 through 310035, 310037 through 310166, 310168, 310170 -310172; ; 310203 through 310413, 333001 through 333028; ; 333030- 333032, 333035 - 333039, 333041 through 333063, 333065 through 333127, 333129 through 333159, 333163 through 333218, 338001- 338003, 3100016, 310050310121, 310050310125, 333072, 333101, 333165, 333170, 52075, 52078.
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Ms. Holly Wright Lee; 440-483-5777
• Manufacturer Reason for Recall: In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
• FDA Determined Cause: Other
• Action: Philips Healthcare issued a Field Safety Notification (FSN)72800720/88200522 1. Identify affected product 2. There are 3 scenarios users may experience which result in identical images that are incorrectly labeled as phase tolerance images. A. When performing a Step and Shoot acquisition with phase tolerance selected, images may be reconstructed identically (a single phase), but are labeled as different phases. This occurs when Start Final Recon is selected prior to display of the ECG wave at the top of the acquisition window. B. When performing a Step and Shoot acquisition with phase tolerance selected, images may be reconstructed identically (a single phase), but are labeled as different phases. This occurs if ECG leads become disconnected mid-acquisition or when the acquisition is halted prematurely due to an application crash. C. By system design, in certain instances when a patient exhibits an arrhythmia or varying heart rate during a Step and Shoot acquisition, images from the acquisition following the heart rate variation, may be labeled in the incorrect phase 4. Determine whether you have a potentially affected system, then determine your AFFECTED PRODUCTS software version. To identify the software version of your product: Click the Help button, Select About and the software version is then displayed, Software versions 4.x, 3.x, and 2.x are potentially affected. 5. Take the Action listed in the field safety notice. Please retain a copy with the equipment Instruction for use. If you need any further information or support concerning this issue, please contact your local Philips representative: North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377 and follow the prompts).
• Quantity in Commerce: 202
• Distribution: Worldwide distribution. US nationwide including Puerto Rico, Canada, Mexico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Cote D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritius, Monaco, Mongolia, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, State of Palestine, Panama, Peru, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, and Yemen
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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