The Recall Desk

FDA (Devices) recall action 72740

GE Medical Systems, LLC recalled 2 products on 2015-12-23

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
2015-12-23
Critical
0
Units
153

Why these products were recalled

GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems.

GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems .

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

1–2 of 2

  • HighFDA (Devices)··2015-12-23

    GE Healthcare Optima IGS 320 Recall for Loss of Displayed Imaging

    GE Medical Systems is recalling 45 Optima IGS 320 systems due to a potential safety issue involving non-recoverable loss of displayed imaging.

    Product
    GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventio
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2015-12-23

    GE Healthcare Recalls Optima CL323i and IGS 320 X-ray Systems

    GE Healthcare is recalling 108 Optima CL323i and Optima IGS 320 angiographic X-ray systems due to a potential loss of displayed imaging.

    Product
    GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and intervention
    Category
    Distribution
    19 states