Z-2317-2026 Class II Ongoing

Recalled by GE Medical Systems, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
June 17, 2026
Initiation Date
April 20, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units

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.

Distribution Pattern

Worldwide - US Nationwide distribution.

Code Information

UDI-DI: 00195278827647; Serial Numbers: DVMSS2500001HL, DVMSS2500002HL, DVMSS2500003HL, DVMSS2500004HL, DVMSS2500005HL, DVMSS2500006HL, DVMSS2600001HL, DVMSS2600002HL