FDA Enforcement
Class II
Ongoing
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Recall: Z-1783-2024
·
Reported May 15, 2024
Enforcement
- Recall Number
- Z-1783-2024
- Event ID
- 94305
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- GE Medical Systems, SCS
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 15, 2024
- Initiation Date
- March 18, 2024
- Classification Date
- May 6, 2024
- Address
- 283 rue de la Miniere, N/A, Buc, N/A, N/A, France
Description
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
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 Info
UDI/DI 00195278719263, Serial Numbers: M3-23-117
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
Quantity
1 unit