The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1201-2019·Announced 2019-04-24

GE Healthcare Recalls Innova IGS 6 X-Ray Systems Due to Imaging Loss

GE Healthcare is recalling 22 Innova IGS 6 Interventional Fluoroscopic X-Ray Systems because they may lose x-ray imaging function during specific field of view changes.

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 the hazard involves a risk-of-harm product (medical imaging failure) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Healthcare, LLC is recalling 22 units of the Innova IGS 6 Interventional Fluoroscopic X-Ray System. These devices are used to generate fluoroscopic and rotational images of human anatomy for cardiovascular, vascular, and non-vascular diagnostic and interventional procedures.

The recall is issued because there is a potential for the loss of x-ray imaging function. This issue can occur when the user changes the field of view (FOV) from 30cm to 20cm, or from 20cm to 30cm, while simultaneously releasing the fluoroscopy footswitch pedal.

The affected devices were distributed nationwide to facilities in Arkansas, California, Florida, Michigan, New Mexico, Nevada, South Carolina, Tennessee, Texas, Virginia, Washington, and Wisconsin. They were 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 further instructions regarding the recall.

The recalled product

Product
Innova IGS 6, Interventional Fluoroscopic X-Ray System 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 — Imaging Equipment
Hazard
Affected units
22

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)

  • Model Number 5771387
  • System ID (Serial Number
  • UDI Number): 501257IGS630 (B3-18-014
  • 01008406821246141118070021B3-18-014)
  • 951486RU630 (B3-18-009
  • 01008406821246141118040021B3-18-009)
  • 714993IGS630 (B3-18-004
  • 01008406821246141118020021B3-18-004)
  • 906225EP1 (B3-18-015
  • 01008406821246141118070021B3-18-015)
  • 906225CATH4 (B3-18-016
  • 01008406821246141118080021B3-18-016)
  • 843797IGS30 (B3-18-030
  • 01008406821246141119010021B3-18-030)
  • 4603984XV41 (B3-18-019
  • 01008406821246141118090021B3-18-019)
  • MCARIGS630 (B3-18-008
  • 01008406821246141118040021B3-18-008)
  • 509473RM1B (B3-18-028
  • 01008406821246141119010021B3-18-028)

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 →

Related recalls

Same manufacturer · GE Healthcare, LLC

See all →

Same hazard · imaging failure

See all →

Similar recalls