Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• 4 recalls, same reason

  • Ongoing Z-2314-2026 FDA Class II ·initiated 20 Apr 2026
  • Ongoing Z-2317-2026 FDA Class II ·initiated 20 Apr 2026
  • Ongoing Z-2315-2026 FDA Class II ·initiated 20 Apr 2026
  • Ongoing Z-2316-2026 FDA Class II ·initiated 20 Apr 2026

  GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

• 7 recalls, same reason

  • Ongoing Z-1779-2024 FDA Class II ·initiated 18 Mar 2024
  • Ongoing Z-1780-2024 FDA Class II ·initiated 18 Mar 2024
  • Ongoing Z-1777-2024 FDA Class II ·initiated 18 Mar 2024
  • Ongoing Z-1783-2024 FDA Class II ·initiated 18 Mar 2024
  • Ongoing Z-1778-2024 FDA Class II ·initiated 18 Mar 2024
  • Ongoing Z-1781-2024 FDA Class II ·initiated 18 Mar 2024
  • Ongoing Z-1782-2024 FDA Class II ·initiated 18 Mar 2024

  GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

• • Ongoing Z-1201-2019 FDA Class II ·initiated 15 Mar 2019

  There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

• • Terminated Z-1864-2021 FDA Class II ·initiated 19 Apr 2021

  The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.

Trade Name

Igs 3 EUDAMED

Allia GUDID

Generic Name

Stationary angiographic x-ray system, digital

Model / Ref / Catalog

Allia, 5874604, IGS 3

Primary DI / UDI-DI

00195278485168

Basic UDI-DI

8406821BUG00099HR

510(k) Number

K232344 ↗ 510(k)

K181403 ↗ GUDID

FDA Product Code

OWB, JAA, IZI

EMDN Code

Z11030102 Stationary angiography systems for angiographic and cardiologic studies

GMDN Term

Stationary angiographic x-ray system, digital

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 892.1650 510(k)GUDID

892.1600 GUDID

EU market of registration

Poland

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• SmartScore 4.0

  Class IIa

  CE/MDD

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  Class IIb

  CE/MDR

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  Class IIa

  CE/MDD

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  Class IIa

  CE/MDR

See all devices from GE Medical Systems SCS →

• What types of procedures can the Allia IGS systems support with their real-time imaging capabilities?

  The Allia IGS systems are designed for real-time fluoroscopic imaging to guide minimally invasive procedures such as vascular access, orthopedic fixation, and electrophysiology studies. Their high-resolution, low-dose imaging helps enhance precision during interventions, reducing patient radiation exposure while supporting a wide range of interventional radiology and surgical applications.

• Are the Allia IGS systems reusable, and if so, what maintenance or sterilization protocols should be followed?

  Yes, the Allia IGS systems are supplied as reusable medical equipment. Maintenance and sterilization protocols are manufacturer-defined, meaning GE Medical Systems SCS provides specific guidelines for cleaning, disinfection, and servicing to ensure proper functionality and safety. Always follow the manufacturer’s instructions to maintain compliance and performance.

• What are the key differences between the Allia IGS 3, 5, 7, and 7 OR models, particularly in terms of image intensifier size and intended use?

  The Allia IGS series varies by image intensifier size: the 3, 5, and 7 refer to the diameter of the intensifier in inches, which affects field of view and imaging flexibility. The Allia IGS 7 OR model is specifically designed for operating room use, likely incorporating additional features or MRI safety ratings tailored for surgical environments. The size selection helps clinicians match the system to procedural needs, such as smaller fields for precise vascular work or larger fields for broader anatomical coverage.

• How is the regulatory status of the Allia IGS systems defined, and what does this mean for purchasing or clinical use?

  The Allia IGS systems hold FDA 510(k) clearance and comply with the EU Medical Device Regulation (MDR), confirming they meet U.S. and European safety and performance standards. This means they are classified as Class II devices under FDA regulations, indicating a moderate risk level that requires compliance with specific controls. For purchasing or clinical use, this ensures the systems undergo rigorous validation but does not imply any specific clinical indication—only that they are authorized for interventional fluoroscopy as described.

• What should buyers consider when selecting between the Allia IGS models for their facility, particularly regarding MRI compatibility?

  Buyers should verify the MRI safety ratings for each model, as the Allia IGS series includes variations with different compatibility levels for MRI environments. While the base models (3, 5, 7) are designed for radiology departments, the Allia IGS 7 OR may offer enhanced MRI safety features for hybrid ORs or facilities requiring seamless integration with MRI systems. Always confirm the specific MRI safety documentation provided by GE Medical Systems SCS to ensure compatibility with your facility’s workflow.