The Recall Desk

FDA (Devices) recall action 81569

Philips Medical Systems (Cleveland) Inc recalled 6 products on 2018-12-12

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
2018-12-12
Critical
0
Units
31,715

Why these products were recalled

There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall

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

  • HighFDA (Devices)··2018-12-12

    Philips Brilliance 16 Slice CT Scanner Recalled for Gantry Cover Separation Risk

    Philips Medical Systems is recalling 6,343 Brilliance 16 Slice CT scanners nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to fall.

    Product
    Brilliance 16 Slice (Power), Model 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. These devices may include signal…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-12-12

    Philips Brilliance 40 CT Systems Recalled for Gantry Cover Separation Risk

    Philips is recalling 6,343 Brilliance 40 CT systems nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to fall.

    Product
    Brilliance 40, Model 728235 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. These devices may include signal analysts and…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-12-12

    Philips Brilliance 10 Slice CT Scanner Recalled for Gantry Cover Failure Risk

    Philips is recalling Brilliance 10 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover and metal support to fail or fall.

    Product
    Brilliance 10 Slice (Air), Model 728251 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. These devices may include signal…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-12-12

    Philips Brilliance 6 Slice CT Scanner Recalled for Gantry Cover Separation Risk

    Philips Medical Systems is recalling Brilliance 6 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or fall.

    Product
    Brilliance 6 Slice (Air), Model 728256 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. These devices may include signal…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-12-12

    Philips Brilliance 16 Slice CT Scanner Recall for Cover Separation

    Philips is recalling Brilliance 16 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or fall.

    Product
    Brilliance 16 Slice (Air), Model 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. These devices may include signal…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-12-12

    Philips Brilliance 64 CT Scanner Recall for Gantry Cover Separation Risk

    Philips Medical Systems is recalling Brilliance 64 CT scanners due to a potential fiberglass resin separation that could cause the gantry front cover to fail and fall.

    Product
    Brilliance 64, Model 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. These devices may include signal analysts and…
    Category
    Distribution
    0 states