[Recalled] GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems — GE HealthCare has become aware of the potential that adhesive material might no… | FDA 2024-03-18

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in France and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from GE Medical Systems, SCS

• Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems — Class II
• Discovery IGS 730 Interventional Fluoroscopic X-ray Systems — Class II
• Senographe Pristina — Class II
• AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 — Class II
• GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems — Class II
• GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.