The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1199-2019·Announced 2019-04-24

GE Healthcare Recalls Innova IGS 630 Angiographic X-Ray System

GE Healthcare is recalling one Innova IGS 630 angiographic X-ray system because a specific user action may cause a loss of imaging function.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

GE Healthcare, LLC is recalling one unit of the Innova IGS 630 Angiographic X-Ray system. The device is used to generate fluoroscopic and rotational images of human anatomy for various diagnostic and interventional procedures. The specific unit is identified by Model Number 5503558, System ID Number 0850060757, and Serial Number B3-16-015.

The recall is due to a potential loss of the x-ray imaging function. This issue can occur if a user changes the field of view (FOV) from 30cm to 20cm, or from 20cm to 30cm, while simultaneously releasing the fluoroscopy footswitch pedal. The agency has classified this recall as Class II.

The device was distributed nationwide to facilities in Arkansas, California, Florida, Michigan, New Mexico, Nevada, South Carolina, Tennessee, Texas, Virginia, Washington, and Wisconsin. It was also distributed internationally to Algeria, Belgium, China, Colombia, France, Hungary, Italy, Japan, Korea (Republic Of), Kuwait, Libya, Pakistan, Poland, Russia, Saudi Arabia, South Africa, Sudan, Turkey, and Vietnam. Users should contact GE Healthcare for instructions on how to resolve the issue.

The recalled product

Product
Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
1

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 (3)

  • Model Number 5503558
  • System ID Number 0850060757
  • Serial Number B3-16-015

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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