FDA-Device2024-05-15Class II
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
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.
Sold states
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
Affected count
1 unit
Manufactured in
283 rue de la Miniere, N/A, Buc, N/A, France
Products
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1783-2024Don't want to check this manually?
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