The Recall Desk

FDA (Devices) recall action 73750

Philips Medical Systems (Cleveland) Inc recalled 7 products on 2016-08-17

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2016-08-17
Critical
0
Units
635

Why these products were recalled

Software defect causing intermittently slow response of Host.

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

1–7 of 7

  • ModerateFDA (Devices)··2016-08-17

    Philips Brilliance BigBore CT Systems Recalled for Software Defect

    Philips is recalling eight Brilliance BigBore Oncology CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance BigBore Oncology Computed Tomography X-ray systems, 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
    46 states
  • ModerateFDA (Devices)··2016-08-17

    Philips Brilliance BigBore CT Systems Recalled for Software Defect

    Philips Medical Systems is recalling 17 Brilliance BigBore CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance BigBore Radiology Computed Tomography X-ray systems, 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
    46 states
  • ModerateFDA (Devices)··2016-08-17

    Philips Ingenuity Core 128 CT Systems Recalled for Software Defect

    Philips is recalling five Ingenuity Core 128 CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Ingenuity Core 128 Computed Tomography X-ray systems is 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
    46 states
  • ModerateFDA (Devices)··2016-08-17

    Philips Brilliance 64 CT Systems Recalled for Software Defect

    Philips Medical Systems is recalling 318 Brilliance 64 Computed Tomography X-ray systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance 64 Computed Tomography X-ray systems is 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
    46 states
  • ModerateFDA (Devices)··2016-08-17

    Philips Ingenuity Core CT Systems Recalled for Software Defect

    Philips Medical Systems is recalling 29 Ingenuity Core CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Ingenuity Core Computed Tomography X-ray systems is 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
    46 states
  • ModerateFDA (Devices)··2016-08-17

    Philips Brilliance 16 CT Systems Recalled for Software Defect

    Philips Medical Systems is recalling 203 Brilliance 16 CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance 16 Computed Tomography X-ray systems is 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
    46 states
  • ModerateFDA (Devices)··2016-08-17

    Philips Brilliance CT 16 Power Systems Recalled for Software Defect

    Philips Medical Systems is recalling 55 Brilliance CT 16 Power systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance CT 16 Power Computed Tomography X-ray systems is 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
    46 states