The Recall Desk

FDA (Devices) recall action 78863

Philips Medical Systems (Cleveland) Inc recalled 4 products on 2018-02-14

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2018-02-14
Critical
0
Units
1,801

Why these products were recalled

Numerous issues related to software Brilliance iCT 4.1.6 software version.

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.

1–4 of 4

  • ModerateFDA (Devices)··2018-02-14

    Philips Ingenuity CT System Recalled for Software Issues

    Philips Medical Systems is recalling Ingenuity CT systems due to software issues in version 4.1.6. The recall affects 26 US government accounts.

    Product
    Philips Ingenuity CT computed tomography x-ray system
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-02-14

    Philips CT System Recalled for Software Issues

    Philips Medical Systems is recalling Ingenuity Core 128 CT systems due to software issues in version 4.1.6.

    Product
    Philips Ingenuity Core 128 computed tomography x-ray system
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-02-14

    Philips Ingenuity Core CT System Software Recall

    Philips Medical Systems is recalling Ingenuity Core CT systems due to software issues in Brilliance iCT 4.1.6.

    Product
    Philips Ingenuity Core computed tomography x-ray system
    Category
    Distribution
    0 states