The Recall Desk

FDA (Devices) recall action 73248

GE Medical Systems, LLC recalled 6 products on 2016-03-16

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
2016-03-16
Critical
0
Units
1,793

Why these products were recalled

GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.

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

1–6 of 6

  • LowFDA (Devices)··2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Service Manual Error

    GE Medical Systems is recalling 25 CT and PET CT scanner systems because their service manuals contain an incorrect torque value.

    Product
    LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole…
    Category
    Distribution
    4 states
  • LowFDA (Devices)··2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Manual Error

    GE Medical Systems is recalling specific CT and PET CT scanners because service manuals contained an incorrect torque value.

    Product
    LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body…
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values

    GE Medical Systems is recalling 522 CT and PET CT scanners worldwide because service manuals contained incorrect torque values.

    Product
    Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation…
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values

    GE Medical Systems is recalling 817 CT and PET CT scanner systems worldwide because service manuals contained incorrect torque values.

    Product
    Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation…
    Category
    Distribution
    4 states
  • LowFDA (Devices)··2016-03-16

    GE Medical Systems Recalls CT and PET Scanners for Incorrect Torque Values

    GE Medical Systems is recalling 104 CT and PET/CT scanners worldwide because service manuals contained incorrect torque values.

    Product
    LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body…
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values

    GE Medical Systems is recalling 324 CT and PET CT scanners worldwide because service manuals contained incorrect torque values.

    Product
    LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body…
    Category
    Distribution
    4 states