iCT SP Model # 728311, computed tomography x-ray system

Reason: 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

Code information: System Serial Number 83001- 83006, 100109, 200003 through 200069, 200071, 200073 through 200138, , 200200 through 200217, 200000261, 200206, 314329, 713513

Distribution pattern: 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