Home / Recalls / Philips Medical Systems (Cleveland) Inc / Z-2189-2019

Z-2189-2019 Class II Terminated

Recalled by Philips Medical Systems (Cleveland) Inc — Cleveland, OH

FDA device recall Z-2189-2019 was initiated by Philips Medical Systems (Cleveland) Inc on June 24, 2019 and is designated Class II. 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 … The recall status is terminated (terminated October 6, 2022). Affected quantity: 128.

Recall Details

Product Type
Devices
Report Date
August 14, 2019
Initiation Date
June 24, 2019
Termination Date
October 6, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
128

Product Description

iCT, Model # 728306, computed tomography x-ray system

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 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

Code Information

System Serial Number 7638, 8306, 10015, 85000 through 85072, 85075 through 85184, 100015- 100016, 100018- 100026, 100028, 100030, 100031, 100032, 100036 through 100079, 100081 through 100236, 100238, 100240 through 100269, 100271 through 100420, 100423 through 100430, 100433 through 100477, 100480 through 100522, , 100600 through 100856, 100858, 200004- 200005 100155, 100184/80924, 239*008, 4263-06, 7203_11, 7621_02, 100272

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  • Z-2192-2019 Class II — IQon Spectral CT Model # 728332, computed tomography x-ray system (June 24, 2019)
  • Z-2193-2019 Class II — Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system (June 24, 2019)

FDA data resources