FDA (Devices) recall action 80176
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
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 specific Ingenuity Core128/Elite X-ray tubes due to a production defect that allows oil leakage, posing a risk to patients and users.
Philips is recalling 28 Ingenuity Core systems due to a production defect in the X-Ray Tube that allows oil leakage, posing a risk to patients or users.
Philips is recalling 28 Brilliance Big Bore Radiology systems due to a production defect in the X-ray tube that allows oil leakage, posing a risk to patients and users.
Philips is recalling 28 Ingenuity Core128 MRI systems because a production defect in the X-Ray Tube allows oil leakage, posing a risk to patients and users.
Philips is recalling 28 Ingenuity TF PET/CT systems due to a production defect in the X-Ray Tube that allows oil leakage, posing a risk to patients or users.