Medical Device Recall: GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
GE Medical Systems, SCS · March 18, 2024
Reason for Recall
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.
Distribution
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
States Affected
NATIONWIDE
Quantity Affected
1 unit
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1783-2024
Status: ongoing
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