The Recall Desk

FDA (Devices) recall action 76483

Philips Medical Systems (Cleveland) Inc recalled 3 products on 2017-03-22

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2017-03-22
Critical
0
Units
3,654

Why these products were recalled

Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

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.

1–3 of 3

  • HighFDA (Devices)··2017-03-22

    Philips BrightView X Nuclear Imaging System Recalled for Four Software and Hardware Issues

    Philips Medical Systems is recalling 1,218 BrightView X nuclear imaging systems worldwide due to four issues: motion controller failures, door interlock problems, detector contact risks, and software freezes.

    Product
    882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studi
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    0 states
  • ModerateFDA (Devices)··2017-03-22

    Philips BrightView Nuclear Imaging Systems Recalled for Motion and Software Issues

    Philips Medical Systems is recalling 1,218 BrightView nuclear imaging systems worldwide due to four issues, including motion controller failures and software freezes.

    Product
    882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies
    Category
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    0 states
  • HighFDA (Devices)··2017-03-22

    Philips BrightView XCT Nuclear Imaging Systems Recalled for Four Hardware Issues

    Philips Medical Systems is recalling 1,218 BrightView XCT nuclear imaging systems worldwide due to four hardware issues, including motion controller failures and door interlock problems.

    Product
    882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated
    Category
    Distribution
    0 states