The Recall Desk

FDA (Devices) recall action 92504

GE OEC Medical Systems, Inc recalled 5 products on 2023-08-09

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2023-08-09
Critical
0
Units
1,796

Why these products were recalled

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

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

1–5 of 5

  • HighFDA (Devices)··2023-08-09

    Image intensifier detachment hazard in OEC fluoroscopy imaging systems

    GE OEC field upgrade kits for fluoroscopy systems may have image intensifiers that detach during movement, potentially falling and causing injuries.

    Product
    Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2023-08-09

    OEC 9900 Systems Image Intensifier Detachment and Fall Risk

    GE OEC 9900 fluoroscopy systems' image intensifiers can detach during movement if subjected to large impact force, potentially falling and causing injuries such as fractures or bruising.

    Product
    OEC 9900 Systems with 9-inch Image Intensifier
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2023-08-09

    OEC 9800 Fluoroscopy Systems Image Intensifier May Detach and Fall

    The image intensifier on GE OEC 9800 fluoroscopy systems can detach and fall if the system experiences a large impact force during movement. This could result in injuries including fractures, bruising, and contusion.

    Product
    OEC 9800 Systems with 9-inch Image Intensifier
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2023-08-09

    OEC Flexiview 8800 Image Intensifier Risks Detachment During Movement

    GE OEC Medical Systems is recalling two OEC Flexiview 8800 fluoroscopic imaging systems due to image intensifiers that may detach and fall during movement, potentially causing fractures, hematoma, contusion, bruise, or pain.

    Product
    OEC Flexiview 8800 Systems with 9-inch Image Intensifier
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2023-08-09

    Medical X-ray Systems Image Intensifier Detachment Injury Risk

    GE OEC Elite Systems with 9-inch Image Intensifier devices may detach during movement if subjected to impact force, potentially causing injury to personnel and bystanders.

    Product
    OEC Elite Systems with 9-inch Image Intensifier
    Category
    Distribution
    51 states