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Allia IGS Pulse angiographic X-ray system

Class II
Recalling firm
GE Medical Systems, LLC
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.
Affected products (lot / model / serial)
UDI-DI: 00195278827647; Serial Numbers: DVMSS2500001HL, DVMSS2500002HL, DVMSS2500003HL, DVMSS2500004HL, DVMSS2500005HL, DVMSS2500006HL, DVMSS2600001HL, DVMSS2600002HL
Units affected
5 units
Distribution pattern
Worldwide - US Nationwide distribution.
Firm location
Waukesha, WI, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-2317-2026
Recall initiated
April 20, 2026
FDA classification date
June 5, 2026
FDA report date
June 17, 2026
FDA event ID
98880
Last updated on HTM Vibe
July 23, 2026
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