Device product
GE Healthcare Innova IGS 5, computed tomography x-ray system
Z-1777-2024
Product summary
- Event
- Event 94305
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21 units
- Official record key
device-enforcement:Z-1777-2024
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 00840682124621, Serial Numbers: M2-23-042, M2-23-046, M2-23-048, M2-23-051, M2-24-001, M3-23-097, M3-23-098, M3-23-106, M3-23-108, M3-23-109, M3-23-111, M3-23-112, M3-23-114, M3-23-116, M3-23-123, M4-23-046, M4-23-053, M4-23-054, M4-23-055, M4-23-056, M4-24-001
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
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.