Ingenuity Core recall
Ingenuity Core Model # 728321, computed tomography x-ray system
Why was Ingenuity Core recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Ingenuity Core Model # 728321, computed tomography x-ray system
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 202
- 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
- Recall date
- August 14, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)