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 and UDI/DI codes.
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 properly applied, which could cause the detector or X-ray tube to fall from the frontal gantry assembly. This fall could injure people nearby during medical procedures.
Healthcare facilities using the recalled Allia IGS 5: 500 units with serial numbers starting with M3-23-117. Medical staff and patients using these systems are at risk if the system falls.
Check for serial numbers starting with M3-23-117 on the system. The UDI/DI code 00195278719263 also identifies affected units. These systems are used for interventional fluoroscopy in medical settings.
Look for serial numbers starting with M3-23-117 on the system.
Reach out to GE Healthcare for further guidance on the recall.
500 units with serial numbers starting with M3-23-117.
The detector or X-ray tube could fall from the frontal gantry assembly due to improper adhesive on some bolts.
No, but you should check the serial number and contact GE Healthcare for guidance.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1783-2024 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1783-2024 from GE Healthcare. 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.
