RecallRadar

FDA Device recall Z-2317-2026

Allia IGS Pulse angiographic X-ray system

On 2026-06-17 the FDA classified a Class II recall of Allia IGS Pulse angiographic X-ray system by Ge Medical Systems, citing 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 electric….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2317-2026
ClassificationClass II
Statusongoing
Initiated2026-04-20
Published2026-06-17
Last updated2026-09-13 11:58 UTC
CompanyGe Medical Systems
DistributionUS

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.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2317-2026%22

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