The Recall Desk

FDA (Devices) recall action 69660

GE OEC Medical Systems, Inc recalled 2 products on 2015-01-21

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2015-01-21
Critical
0
Units
122

Why these products were recalled

mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).

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.

1–2 of 2

  • ModerateFDA (Devices)··2015-01-21

    GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Recall for Accuracy Issues

    GE OEC Medical Systems is recalling 61 mobile C-Arm X-ray units because their accuracy may exceed the design specification of +10%.

    Product
    GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-01-21

    GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Recall for Accuracy Deviation

    GE OEC Medical Systems is recalling 61 mobile C-Arm X-ray units because the accuracy of the x-ray tube potential and current may exceed the manufacturer's specified limits.

    Product
    GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
    Category
    Distribution
    0 states