GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
Reported: May 15, 2024 Initiated: March 18, 2024 #Z-1781-2024
Product Description
GE Healthcare Allia IGS 7 OR, 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.
Details
- Recalling Firm
- GE Medical Systems, SCS
- Units Affected
- 2 units
- 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
- Location
- Buc, N/A
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems. Recalled by GE Medical Systems, SCS. Units affected: 2 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2024. Severity: Moderate. Recall number: Z-1781-2024.
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