GE Healthcare recalls Allia IGS 7 interventional fluoroscopy systems due to potential bolt adhesive issues that could cause detector or X-ray tube falls. Affected units have specific serial numbers.
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.
GE Healthcare is recalling certain Allia IGS 7 interventional fluoroscopy systems because adhesive on some bolts might not be properly applied. This could cause the detector or X-ray tube to fall, potentially causing injury.
The adhesive material on bolts might not be properly applied, which could cause the detector or X-ray tube to fall from the frontal gantry assembly. This poses a risk of injury to patients or staff during medical procedures.
Healthcare facilities using the recalled Allia IGS 7 systems are most at risk, as improper bolt adhesion could lead to equipment failure during procedures.
Check for serial numbers D4-23-035, D4-23-036, D4-23-038, D4-23-042, D4-24-001, or D4-24-003 on the equipment. These units were sold with specific UDI/DI numbers.
Look for the serial numbers D4-23-035, D4-23-036, D4-23-038, D4-23-042, D4-24-001, or D4-24-003 on the equipment.
The adhesive material on some bolts might not be properly applied, which could cause the detector or X-ray tube to fall from the frontal gantry assembly.
Check for serial numbers D4-23-035, D4-23-036, D4-23-038, D4-23-042, D4-24-001, or D4-24-003 on the equipment.
No, but healthcare facilities should check the serial numbers and contact GE Healthcare if affected.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1780-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-1780-2024 from GE Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.