FDA recall Z-1783-2024

GE Medical Systems, SCS · Class II · device

Product

GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems

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

Key facts

Status
Ongoing
Initiation date
2024-03-18
Report date
2024-05-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Buc, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1783-2024