Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1783-2024 — GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems

U.S. FDA — Device Enforcement · France · 2024-03-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1783-2024
Date of alert
2024-03-18
Country / jurisdiction
France
Risk level
Class II
Risk type
recall
Brand
GE Medical Systems, SCS
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00195278719263
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.