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Recall Observatory FDA recall evidence

Device product

GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems

Z-1780-2024

March 18, 2024

Class II

Product summary

Firm
GE Medical Systems, SCS
Event
Event 94305
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-1780-2024

Official wording

Reason: 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.

Code information: UDI/DI 00195278215543, Serial Numbers: D4-23-035, D4-23-036, D4-23-038, D4-23-042, D4-24-001, D4-24-003

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.