The Recall Desk

FDA (Devices) recall action 74820

Philips Medical Systems (Cleveland) Inc recalled 7 products on 2016-08-31

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
2016-08-31
Critical
0
Units
615

Why these products were recalled

After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.

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)··2016-08-31

    Philips Brilliance CT 16 Power Software Defect Recall

    Philips is recalling 50 Brilliance CT 16 Power systems due to a software defect that may cause planned anatomy to be cut off in images, potentially requiring a rescan.

    Product
    Brilliance CT 16 Power, Model number 728240 Product Usage: 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
    47 states
  • ModerateFDA (Devices)··2016-08-31

    Philips Brilliance 16 CT Scanner Recalled for Image Reconstruction Defect

    Philips Medical Systems is recalling 192 Brilliance 16 CT scanners because a software upgrade can cause planned anatomy to be cut off in images, potentially requiring a rescan.

    Product
    Brilliance 16, Model number 728246 Product Usage: 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
    47 states
  • HighFDA (Devices)··2016-08-31

    Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Defect

    Philips is recalling three Ingenuity Core128 CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.

    Product
    Ingenuity Core128, Model number 728323 Product Usage: 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
    47 states
  • ModerateFDA (Devices)··2016-08-31

    Philips Brilliance CT Big Bore Oncology Software Recall

    Philips is recalling 33 Brilliance CT Big Bore Oncology systems due to a software defect that may cause planned anatomy to be cut off in gated helical CT images.

    Product
    Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: 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
    47 states
  • ModerateFDA (Devices)··2016-08-31

    Philips Brilliance 64 CT Scanner Recalled for Image Reconstruction Errors

    Philips is recalling 283 Brilliance 64 CT scanners because a software update can cause planned anatomy to be cut off in images, potentially requiring a rescan.

    Product
    Brilliance 64 CT Model number 728231 Product Usage: 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
    47 states
  • ModerateFDA (Devices)··2016-08-31

    Philips Brilliance BigBore CT Scanner Recalled for Image Reconstruction Error

    Philips is recalling 24 Brilliance BigBore CT scanners because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.

    Product
    Brilliance BigBore Radiology CT Model number 728244 Product Usage: 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
    47 states
  • HighFDA (Devices)··2016-08-31

    Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Defect

    Philips is recalling 30 Ingenuity Core CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scans.

    Product
    Ingenuity Core, Model number 728321 Product Usage: 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
    47 states