The Recall Desk

FDA (Devices) recall action 78144

Philips Electronics North America Corporation recalled 6 products on 2017-10-25

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
2017-10-25
Critical
0
Units
3,636

Why these products were recalled

During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.

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.

1–6 of 6

  • ModerateFDA (Devices)··2017-10-25

    Philips Brilliance iCT SP CT Systems Recalled for Image Reconstruction Failure

    Philips is recalling Brilliance iCT SP CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.

    Product
    Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are 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
    0 states
  • ModerateFDA (Devices)··2017-10-25

    Philips Brilliance 64 CT Systems Recalled for Image Reconstruction Failure

    Philips Electronics North America Corporation is recalling 606 Brilliance 64 CT systems in the US because a software defect prevents image reconstruction after certain scans.

    Product
    Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are 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
    0 states
  • ModerateFDA (Devices)··2017-10-25

    Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Failure

    Philips is recalling 606 Ingenuity Core CT systems in the US because a software defect prevents image reconstruction after bolus tracking scans.

    Product
    Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are 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
    0 states
  • ModerateFDA (Devices)··2017-10-25

    Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Failure

    Philips is recalling Ingenuity Core128 CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patient rescans.

    Product
    Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-ray systems are 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
    0 states
  • ModerateFDA (Devices)··2017-10-25

    Philips Ingenuity CT Systems Recalled for Bolus Tracking Image Failure

    Philips is recalling Ingenuity CT systems because a software defect prevents image generation during bolus tracking procedures, potentially requiring patient rescans.

    Product
    Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are 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
    0 states
  • ModerateFDA (Devices)··2017-10-25

    Philips Brilliance iCT CT Scanner Recall for Data Reconstruction Failure

    Philips is recalling Brilliance iCT CT scanners because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.

    Product
    Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are 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
    0 states