FDA (Devices) recall action 83365
The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Philips is recalling 116 CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Philips is recalling 27 iCT SP computed tomography systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
Philips is recalling 12 Ingenuity TF PET/CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Philips is recalling 128 iCT computed tomography systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Philips is recalling 92 Ingenuity CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Philips is recalling Ingenuity Core CT systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
Philips is recalling 582 Brilliance 64 CT systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
Philips is recalling 26 Vereos PET/CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Philips is recalling 25 IQon Spectral CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.