The Recall Desk

FDA (Devices) recall action 72974

GE Medical Systems, LLC recalled 3 products on 2016-02-17

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
2016-02-17
Critical
0
Units
3,410

Why these products were recalled

Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.

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

1–3 of 3

  • HighFDA (Devices)··2016-02-17

    GE Healthcare Optima XR220amx Mobile Radiographic System Recalled for Safety Latch Failure

    GE Medical Systems is recalling 2,389 Optima XR220amx mobile radiographic systems worldwide due to a potential safety latch mechanism failure that could cause the arm assembly to fall.

    Product
    GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2016-02-17

    GE Brivo XR285amx Mobile Radiographic System Recalled for Safety Latch Failure

    GE Medical Systems is recalling 126 Brivo XR285amx mobile radiographic systems worldwide because a safety latch mechanism may fail, posing a risk of bodily harm.

    Product
    GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2016-02-17

    GE Healthcare Optima XR200amx Mobile Radiographic System Recalled for Safety Latch Failure

    GE Medical Systems is recalling 895 Optima XR200amx mobile radiographic systems worldwide due to a potential safety latch mechanism failure that could cause the arm assembly to fall.

    Product
    GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
    Category
    Distribution
    4 states