GE Healthcare Allia IGS Fluoroscopic Systems Recall: Missing Adhesive
GE Healthcare recalls Allia IGS and related interventional fluoroscopic x-ray systems due to potentially missing adhesive on bolts. The defect could allow the detector/elevator or x-ray tube in the gantry assembly to fall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall where adhesive failure on bolts could allow equipment to fall in a medical facility environment. This is a risk-of-harm product with no reported injuries or deaths, meeting the rubric criterion for High severity.
Plain-English summary
GE Healthcare has issued a recall for Allia IGS and related interventional fluoroscopic x-ray systems, including Innova IGS, Discovery IGS, Interact IGS, and Allia Pulse IGS models. These systems are used in medical facilities for diagnostic and interventional imaging procedures.
The recall affects units where adhesive material may not have been properly applied to certain bolts in the frontal gantry assembly. This defect could result in the detector/elevator or x-ray tube becoming loose and potentially falling during operation or maintenance.
Affected units have been distributed worldwide, with documented distribution to medical facilities in California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, and to multiple countries including Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, and Vietnam.
Medical facilities with affected equipment (Serial Number M3-23-117, UDI/DI 00195278719263) should contact GE Healthcare for guidance on inspection and corrective action to ensure proper adhesive application to all bolts before continued use.
The recalled product
- Product
- GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
- Manufacturer
- GE Medical Systems, SCS
- Affected units
- 1
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 (2)
- UDI/DI 00195278719263
- Serial Numbers: M3-23-117
Distribution
Part of a larger recall action
This product is one of 7 recalled by GE Medical Systems, SCS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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