GE Healthcare recalls Allia IGS 5 Pulse 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 5 Pulse 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 on some bolts might not be applied correctly, which could cause the detector or X-ray tube to fall from the gantry. This poses a risk of injury to people nearby during medical procedures.
Healthcare facilities using the recalled Allia IGS 5 Pulse systems are most at risk, particularly those with specific serial numbers listed in the recall.
Check for serial numbers starting with M3-23-117 on the Allia IGS 5 Pulse systems. The recall covers specific units with UDI/DI 00195278719263.
Look for serial numbers starting with M3-23-117 on the system.
GE Healthcare has become aware that adhesive might not have been applied to some bolts on certain models, which could cause the detector or X-ray tube to fall.
The detector or X-ray tube could fall from the gantry, potentially causing injury to people nearby during medical procedures.
Check for serial numbers starting with M3-23-117 on the Allia IGS 5 Pulse system. The recall covers units with UDI/DI 00195278719263.
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-1782-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-1782-2024 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.
