Ingenuity CT, Model # 728326, computed tomography x-ray system
This recall has been terminated (originally issued August 6, 2019).
- Recall Initiated
- June 24, 2019
- Posted
- August 6, 2019
- Terminated
- October 6, 2022
- Recall Number
- Z-2186-2019
- Quantity
- 92
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
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
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
Lot / Code Info
System Serial Number 10474, 30003, 30005, 30006 through 30009, 30011 through 30015, 30017 through 30050, 30053-30054, 30056, 52035, 52049,52051,100367 122276, 300003 Through 300005, 300010 through 300012, 300014, 300016 through 300066, 300068 through 300135, 300136 through 300145, 300147 through 300151, 300153- 300154, 300156 through 300166, 300200 through 300263, 320127, 336053, 339001, 339007, 339008, 339009, 30004-1, 336124
Root Cause
Other
Action Taken
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).