The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1777-2024·Announced 2024-05-15

GE Healthcare X-Ray Systems Recalled for Loose Bolts on Gantry Assembly

GE Healthcare is recalling x-ray imaging systems because adhesive on critical bolts may not have been applied, potentially causing the detector or x-ray tube to fall. The recall affects 21 units worldwide.

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: FDA Class II recall. The adhesive defect on critical bolts poses a structural risk that could cause equipment collapse and potential injury, but no illnesses or injuries are reported in the source. Per the rubric, risk-of-harm products where injury has not yet been reported score as High severity.

Plain-English summary

GE Healthcare Innova IGS 5 and related x-ray imaging systems (Discovery IGS, Interact IGS, Allia IGS, and Allia Pulse IGS) are being recalled due to a manufacturing defect. The adhesive material that secures critical bolts on the frontal gantry assembly may not have been applied to some units during manufacturing. This could allow the detector or x-ray tube assembly to fall, creating a potential hazard to patients and medical staff.

The recall affects 21 units with specific serial numbers, distributed worldwide including the United States (California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia) and multiple countries (Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam).

Healthcare facilities with affected equipment should immediately contact GE Medical Systems for repair or replacement instructions. Customers can identify affected units by their serial number.

The recalled product

Product
GE Healthcare Innova IGS 5, computed tomography x-ray system
Manufacturer
GE Medical Systems, SCS
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
Affected units
21

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)

  • UDI/DI 00840682124621
  • Serial Numbers: M2-23-042
  • M2-23-046
  • M2-23-048
  • M2-23-051
  • M2-24-001
  • M3-23-097
  • M3-23-098
  • M3-23-106
  • M3-23-108
  • M3-23-109
  • M3-23-111
  • M3-23-112
  • M3-23-114
  • M3-23-116
  • M3-23-123
  • M4-23-046
  • M4-23-053
  • M4-23-054
  • M4-23-055

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 7 recalled by GE Medical Systems, SCS 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 7 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems, SCS

See all →

Same hazard · adhesive failure

See all →

Similar recalls