Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2019 - (Recall #: Z-2189-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 24, 2019

Date Posted: August 14, 2019

Recall Number: Z-2189-2019

Event ID: 83365

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

Status: Terminated

Product Quantity: 128

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

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

Voluntary or Mandated:

Voluntary: Firm initiated