medical Class II Updated 2019-08-14

Philips Medical Systems (Cleveland) Inc recalls iCT SP Model # 728311, computed tomography x-ray system

Recalled Product

iCT SP Model # 728311, computed tomography x-ray system


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: System Serial Number 83001- 83006, 100109, 200003 through 200069, 200071, 200073 through 200138, , 200200 through 200217, 200000261, 200206, 314329, 713513
View official government recall

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