The Recall Desk

FDA (Devices) recall action 71124

Philips Medical Systems (Cleveland) Inc recalled 6 products on 2015-08-05

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2015-08-05
Critical
0
Units
424

Why these products were recalled

5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict

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.

States named across these recalls

1–6 of 6

  • HighFDA (Devices)··2015-08-05

    Philips Ingenuity CT Scanners Recalled for Software and Hardware Defects

    Philips is recalling 159 Ingenuity CT scanners due to software errors affecting dose control, image artifacts, and heart rate measurement.

    Product
    Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Distribution
    33 states
  • HighFDA (Devices)··2015-08-05

    Philips CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 82 Ingenuity Core CT systems due to software errors affecting image quality, dose control, and heart rate monitoring.

    Product
    Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Distribution
    33 states
  • HighFDA (Devices)··2015-08-05

    Philips Brilliance iCT SP CT Systems Recalled for Software Defects

    Philips Medical Systems is recalling two Brilliance iCT SP CT systems due to software issues affecting image quality, dose control, and heart rate measurement.

    Product
    Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Distribution
    33 states
  • HighFDA (Devices)··2015-08-05

    Philips Brilliance iCT CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 38 Brilliance iCT CT systems due to software errors affecting dose control, heart rate measurement, and image artifacts.

    Product
    Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Distribution
    33 states
  • HighFDA (Devices)··2015-08-05

    Philips CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 139 Ingenuity Core 128 CT scanners due to software errors affecting image quality, dose control, and heart rate monitoring.

    Product
    Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2015-08-05

    Philips Brilliance CT 64-Channel Systems Recalled for Software Defects

    Philips is recalling four Brilliance CT 64-channel systems due to software errors affecting image quality, dose control, and heart rate measurements.

    Product
    Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Distribution
    33 states