The Recall Desk

FDA (Devices) recall action 79088

Philips Medical Systems (Cleveland) Inc recalled 5 products on 2018-02-14

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2018-02-14
Critical
0
Units
6,935

Why these products were recalled

During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

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.

1–5 of 5

  • HighFDA (Devices)··2018-02-14

    Philips BrightView X Gamma Cameras Recalled for Collimator Drop Risk

    Philips Medical Systems is recalling BrightView X gamma cameras because collimators may drop to the floor during exchange, posing a physical hazard.

    Product
    BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic,
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-02-14

    Philips Precedence 6 Imaging System Recalled for Collimator Drop Risk

    Philips is recalling 1,387 Precedence 6 imaging systems because collimators may drop to the floor during exchange, posing a risk of injury.

    Product
    Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenua
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-02-14

    Philips BrightView Gamma Cameras Recalled for Collimator Drop Risk

    Philips Medical Systems is recalling BrightView Model 882480 gamma cameras because collimators may drop to the floor during exchange, posing a physical hazard.

    Product
    BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gat
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-02-14

    Philips BrightView XCT Gamma Camera Recalled for Collimator Drop Risk

    Philips Medical Systems is recalling BrightView XCT gamma cameras because a collimator may drop to the floor during exchange, posing a risk of injury.

    Product
    BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SP
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-02-14

    Philips Precedence 16 Imaging System Recalled for Collimator Drop Risk

    Philips is recalling 1,387 Precedence 16 imaging systems because collimators may drop to the floor during exchange, posing a physical hazard.

    Product
    Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenu
    Category
    Distribution
    0 states