The Recall Desk

FDA (Devices) recall action 73961

Philips Medical Systems (Cleveland) Inc recalled 4 products on 2016-06-08

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
2016-06-08
Critical
0
Units
1,097

Why these products were recalled

The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.

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

1–4 of 4

  • ModerateFDA (Devices)··2016-06-08

    Philips Ingenuity Core CT Systems Recalled for Drive Mapping Issue

    Philips is recalling 300 Ingenuity Core CT systems because they may fail to map the Varian drive after a user logs out and back in.

    Product
    Ingenuity Core Computed Tomography X-ray Systems, Product Usage: 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
    45 states
  • ModerateFDA (Devices)··2016-06-08

    Philips Brilliance 64 CT Systems Recalled for Software Mapping Error

    Philips Medical Systems is recalling 158 Brilliance 64 CT systems because the software may fail to map the Varian drive after a user logs out and back in.

    Product
    Brilliance 64 Computed Tomography X-ray Systems Product Usage: 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
    45 states
  • ModerateFDA (Devices)··2016-06-08

    Philips Ingenuity CT Systems Recalled for Drive Mapping Issue

    Philips is recalling 215 Ingenuity CT systems because they may fail to map the Varian drive after a user logs out and back in.

    Product
    Ingenuity Computed Tomography X-ray Systems Product Usage: 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
    45 states
  • ModerateFDA (Devices)··2016-06-08

    Philips Ingenuity Core 128 CT Systems Recalled for Drive Mapping Issue

    Philips Medical Systems is recalling 424 Ingenuity Core 128 CT systems because the system may not map the Varian drive after a user logout and login.

    Product
    Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: 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
    45 states