The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1200-2019·Announced 2019-04-24

GE Healthcare Recalls Innova IGS 630 X-Ray Systems for Imaging Loss

GE Healthcare is recalling 49 Innova IGS 630 Interventional Fluoroscopic X-Ray Systems due to a potential loss of x-ray imaging function when changing the field of view while releasing the footswitch.

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) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Healthcare, LLC is recalling 49 units of the Innova IGS 630 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 the 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. International distribution included Algeria, Belgium, China, Colombia, France, Hungary, Italy, Japan, Korea (Republic Of), Kuwait, Libya, Pakistan, Poland, Russia, Saudi Arabia, South Africa, Sudan, Turkey, and Vietnam. The FDA has classified this recall as Class II.

The recalled product

Product
Innova IGS 630, 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
49

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 5730860
  • System ID (Serial Number
  • UDI Number): 352333VASC3 (B3-17-006
  • 01008406821086381117020021B3-17-006)
  • 727869SPECIALS (B3-18-005
  • 01008406821086381118020021B3-18-005)
  • 407518BIPLANE (B3-17-005
  • 01008406821086381117010021B3-17-005)
  • 305227KBP630 (B3-16-017
  • 01008406821086381116080021B3-16-017)
  • 401BIPLANE1 (B3-18-001
  • 01008406821086381118010021B3-18-001)
  • 941629IGS630 (B3-18-002
  • 01008406821086381118010021B3-18-002)
  • 505841CATH3 (B3-17-032
  • 01008406821086381117120021B3-17-032)
  • 7022553131 (B3-17-011
  • 01008406821086381117030021B3-17-011)
  • 7028803131 (B3-17-023
  • 01008406821086381117080021B3-17-023)

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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