The Recall Desk

FDA (Devices) recall action 76716

Philips Medical Systems (Cleveland) Inc recalled 4 products on 2017-04-12

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2017-04-12
Critical
0
Units
201

Why these products were recalled

The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

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

1–4 of 4

  • HighFDA (Devices)··2017-04-12

    Philips BrightView X Gamma Camera Recall for Brake Hub Assembly Error

    Philips is recalling BrightView X 3/4 gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView X 3/4 model number 882479 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, gated…
    Category
    Distribution
    29 states
  • HighFDA (Devices)··2017-04-12

    Philips BrightView XCT Gamma Cameras Recalled for Brake Hub Assembly Error

    Philips is recalling 90 BrightView XCT gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView XCT model number 882482 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, gated, and…
    Category
    Distribution
    29 states
  • ModerateFDA (Devices)··2017-04-12

    Philips BrightView X Gamma Camera Recall Due to Brake Hub Assembly Error

    Philips Medical Systems is recalling 27 BrightView X gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView X 3/8 model number 882478 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, gated…
    Category
    Distribution
    29 states
  • HighFDA (Devices)··2017-04-12

    Philips Recalls 84 BrightView SPECT Gamma Cameras Due to Brake Hub Defect

    Philips is recalling 84 BrightView SPECT gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView SPECT model number 882480 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, gated…
    Category
    Distribution
    29 states