GE Allia IGS Fluoroscopic X-Ray Systems Adhesive Bolt Defect
GE Healthcare recalled certain Allia IGS and related fluoroscopic x-ray systems due to potential incomplete adhesive on bolts in the gantry assembly, risking detector or tube failure.
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: This is a Class II FDA medical device recall involving a structural defect with potential for serious injury to patients or staff (equipment falling), though no injuries or deaths have been reported. The hazard is risk-of-harm but theoretical.
Plain-English summary
GE Healthcare has issued a recall of certain Allia IGS 7 OR and related interventional fluoroscopic x-ray systems manufactured by GE Medical Systems, SCS, due to a potential manufacturing defect affecting bolt adhesive application.
According to the FDA, the recalled systems may have incomplete adhesive material applied to certain bolts in the frontal gantry assembly. This defect could result in a potential fall of the detector/elevator or x-ray tube, creating a potential risk to patients and staff.
Two units have been identified in the recall (serial numbers D3-23-026 and D4-24-002). The affected systems have been distributed worldwide, including to multiple U.S. states (California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia) and internationally (Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam).
The recalled product
- Product
- GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
- Manufacturer
- GE Medical Systems, SCS
- Hazard
- adhesive-defect
- equipment-fall
- structural-failure
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 (3)
- UDI/DI 00195278215550
- Serial Numbers: D3-23-026
- D4-24-002
Distribution
Distributed nationwide across the United States.
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