medical Class II Updated 2019-08-14

Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core128 Model # 728323, computed tomography x-ray

Recalled Product

Ingenuity Core128 Model # 728323, 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 6123, 30016, 30023, 300068, 30153, 32000 through 320513, 52023, 52028 336001 through 336038, 336040 through 336051, 336053, 336055 through 336061, 336063 through 336379, 336382 through 336454, 336701 through 336811, 345218, 760014, 21003-05, 320309, 32053, 32060, 336039-1 336143, 336147, 336331, 7175_06
View official government recall

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