The Recall Desk

FDA (Devices) recall action 73338

Philips Medical Systems (Cleveland) Inc recalled 6 products on 2016-04-20

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
2016-04-20
Critical
0
Units
1,002

Why these products were recalled

The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.

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

  • ModerateFDA (Devices)··2016-04-20

    Philips Ingenuity CT Systems Recalled for Software Error in Data Transmission

    Philips Medical Systems is recalling 82 Ingenuity CT systems due to a software error that may prevent the automatic transmission of image data to remote devices.

    Product
    Ingenuity CT 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
    43 states
  • ModerateFDA (Devices)··2016-04-20

    Philips Brilliance iCT SP CT Systems Recalled for Software Error

    Philips is recalling 49 Brilliance iCT SP CT systems due to a software error that may prevent automatic transmission of image data to remote devices.

    Product
    Brilliance iCT SP 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
    43 states
  • ModerateFDA (Devices)··2016-04-20

    Philips Brilliance 64 CT Systems Recalled for Software Data Transmission Error

    Philips Medical Systems is recalling 285 Brilliance 64 CT systems because a software error may prevent the automatic transmission of all image and data series to remote devices.

    Product
    Brilliance 64: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
    43 states
  • ModerateFDA (Devices)··2016-04-20

    Philips Ingenuity Core 128 CT Systems Recalled for Software Error

    Philips is recalling 174 Ingenuity Core 128 CT systems due to a software error that may prevent automatic transmission of image data to remote devices.

    Product
    Ingenuity Core 128 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
    43 states
  • ModerateFDA (Devices)··2016-04-20

    Philips Brilliance iCT CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 324 Brilliance iCT Computed Tomography systems due to a software error that may prevent automatic transmission of image data to remote devices.

    Product
    Brilliance iCT 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
    43 states
  • ModerateFDA (Devices)··2016-04-20

    Philips Ingenuity Core CT Systems Recalled for Software Error

    Philips is recalling 88 Ingenuity Core CT systems because a software error may prevent automatic transmission of image data to remote devices.

    Product
    Ingenuity Core 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
    43 states