GE Innova IGS Fluoroscopic X-Ray Systems Adhesive Defect Recall
GE Healthcare is recalling certain Innova IGS x-ray systems due to potential adhesive defects on component bolts. Missing adhesive could cause the detector or x-ray tube to fall during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of medical x-ray equipment with risk-of-harm from potentially falling components. No reported injuries or deaths. Classified as High per the rubric for risk-of-harm products without yet-reported incidents.
Plain-English summary
GE Healthcare is recalling certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS, and Allia Pulse IGS interventional fluoroscopic x-ray systems. The recalled units have serial numbers B3-23-015, B3-23-016, or B3-24-002.
The recall is due to a potential defect in the assembly process where adhesive material might not have been applied to certain bolts on the frontal gantry assembly. This could result in a potential fall of the detector/elevator or x-ray tube.
These units have been distributed worldwide, including in the United States in California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, and Virginia. International distribution includes Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, and Vietnam.
The recalled product
- Product
- GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
- Manufacturer
- GE Medical Systems, SCS
- Hazard
- structural-defect
- equipment-fall
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI 00840682124614
- Serial Numbers: B3-23-015
- B3-23-016
- B3-24-002
Distribution
Distributed nationwide across the United States.
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