GE Healthcare X-ray Systems: Potential Adhesive Failure Poses Fall Hazard
GE Healthcare is recalling certain Allia and Discovery IGS x-ray systems due to potential adhesive failure that could cause the detector, elevator, or x-ray tube to fall. No injuries reported.
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 an FDA Class II recall with no reported injuries or incidents. The hazard is a potential structural failure that could result in equipment components falling. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
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 worldwide. These diagnostic imaging systems are used in medical facilities for interventional and diagnostic imaging procedures.
The recall was initiated because adhesive material may not have been properly applied to certain bolts on these systems. This potential adhesive failure could result in the detector assembly, elevator, or x-ray tube falling from the frontal gantry. A falling component could potentially cause injury to patients or medical personnel near the equipment.
The affected systems have been distributed across the United States and internationally. Healthcare facilities operating these systems should contact GE Medical Systems regarding this recall.
The recalled product
- Product
- GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
- Manufacturer
- GE Medical Systems, SCS
- Hazard
- adhesive-failure
- fall-hazard
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
Distributed nationwide across the United States.
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