GE Healthcare recalls Innova IGS 6 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 Innova IGS 6 interventional fluoroscopy systems because adhesive on some bolts might not be properly applied. This could cause the X-ray detector or 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. This fall could injure people nearby during medical procedures.
Healthcare facilities using the recalled Innova IGS 6 systems are most at risk. Patients and staff during procedures may be affected if the system malfunctions.
Check for serial numbers B3-23-015, B3-23-016, or B3-24-002 on the system. The product is an Innova IGS 6 interventional fluoroscopy system from GE Healthcare.
Look for serial numbers B3-23-015, B3-23-016, or B3-24-002 on the system.
The detector or X-ray tube could fall, potentially causing injury to people nearby during medical procedures.
Check for serial numbers B3-23-015, B3-23-016, or B3-24-002 on the Innova IGS 6 interventional fluoroscopy system.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1778-2024 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1778-2024 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.
