medical Class II Updated 2019-08-14

Philips Medical Systems (Cleveland) Inc recalls Ingenuity CT, Model # 728326, computed tomography x-ray sy

Recalled Product

Ingenuity CT, Model # 728326, 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 10474, 30003, 30005, 30006 through 30009, 30011 through 30015, 30017 through 30050, 30053-30054, 30056, 52035, 52049,52051,100367 122276, 300003 Through 300005, 300010 through 300012, 300014, 300016 through 300066, 300068 through 300135, 300136 through 300145, 300147 through 300151, 300153- 300154, 300156 through 300166, 300200 through 300263, 320127, 336053, 339001, 339007, 339008, 339009, 30004-1, 336124
View official government recall

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