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GE Medical Systems, SCS recalls GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Recalled May 15, 2024 · FDA recall Z-1783-2024 · GE Medical Systems, SCS
Hazard
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. · FDA Class II
Units
1 unit
Sold at
Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam
Description
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.
Product
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Manufacturer(s)
GE Medical Systems, SCS
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →