Recall Z-2317-2026— GE Medical Systems, LLC

Name: FDA recall Z-2317-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-20

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2026-04-20. It names one FDA 510(k) clearance: K232344. Product: Allia IGS Pulse angiographic X-ray system. Reason: 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..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-04-20
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K232344 — Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS·cleared 2023-10-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Allia IGS Pulse angiographic X-ray system

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.