Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2019 - (Recall #: Z-2188-2019)

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:

Ingenuity Core Model # 728321, computed tomography x-ray system

Product Classification:

Class II

Date Initiated: June 24, 2019

Date Posted: August 14, 2019

Recall Number: Z-2188-2019

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: 202

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.

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