The Recall Desk
HighFDA (Devices)·Z-1864-2021·Announced 2021-06-23

GE Healthcare X-Ray Systems Affected by Display Image Distortion Defect

GE Healthcare interventional x-ray imaging systems can develop a display defect that splits and distorts live monitor images into two unequal parts. The defect affects 139 devices with worldwide distribution.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall affecting interventional imaging equipment used in critical clinical procedures. While no adverse events have been reported, the display defect creates a credible risk of harm by impairing image quality during interventional procedures, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare has initiated a recall of Innova IGS 3, IGS 5, IGS 6, and Discovery IGS 7 and IGS 7 OR interventional fluoroscopic x-ray systems. These devices provide live fluoroscopic imaging during interventional medical procedures. The recall affects 139 devices.

The systems can experience a defect where a single vertical line divides and horizontally shifts the live monitor image, splitting the display into two unequal parts. This image distortion occurs on the monitor screen.

Devices were distributed worldwide and across multiple US states including California, Colorado, Florida, Georgia, Kentucky, Louisiana, Massachusetts, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and Wisconsin. Some devices were distributed to government facilities and potentially military facilities. International distribution includes countries in North Africa, South America, Europe, Asia, the Middle East, and other regions.

GE Healthcare, LLC is the manufacturing company responsible for this recall.

The recalled product

Product
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Interventional Fluoroscopy Systems
Hazard
Affected units
139

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Affected serial numbers: B2-20-006
  • B2-20-007
  • B2-20-008
  • B2-20-009
  • B2-21-001
  • B3-20-024
  • B3-20-026
  • B3-20-027
  • B3-20-028
  • B3-21-001
  • B3-21-002
  • B3-21-003
  • B3-21-006
  • D3-20-025
  • D3-20-028
  • D3-20-029
  • D3-21-002
  • D3-21-005
  • D3-21-006
  • D3-21-007

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

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