Ingenuity Core Model # 728321, computed tomography x-ray system
Check against the official notice below — it lists the full affected range.
Philips Medical Systems is recalling 202 Ingenuity Core Model #728321 computed tomography x-ray systems distributed worldwide, including throughout the United States, Puerto Rico, Canada, Mexico, and numerous other countries. The systems are affected by a labeling issue where images from certain cardiac step and shoot acquisitions may be incorrectly labeled as if phase tolerance had been applied when phase tolerance had not actually been applied.
The recall affects systems with specific serial numbers ranging from 10634 through 333218, with numerous individual serial numbers identified. The source document does not specify what remedy affected consumers should undertake.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: 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, Esto Quantity: 202 Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.