Interact Discovery RT X-ray Systems Recalled for Component Fall Risk
GE Healthcare is recalling certain x-ray systems because adhesive material may not be properly attached to bolts, which could cause components to fall during use.
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 recall of medical device with structural defect (missing adhesive) allowing potential component fall. Severity is High due to serious injury risk from falling heavy components in medical equipment, but does not reach Severe as this is Class II without reported hospitalizations.
Plain-English summary
GE Healthcare is recalling certain Interact Discovery RT, Discovery IGS, Innova IGS, Allia IGS, and Allia Pulse IGS interventional fluoroscopic x-ray systems. The recall involves one unit identified by serial number M4-23-049 and UDI/DI 00840682141581.
The recall was initiated because adhesive material may not have been properly applied to bolts in the frontal gantry assembly of affected systems. This could result in the detector/elevator or x-ray tube falling during use.
The affected systems have been distributed worldwide, including throughout the United States in California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, and Virginia. International recipients include Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, and Vietnam.
The recalled product
- Product
- GE Healthcare Interact Discovery RT, 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 00840682141581
- Serial Numbers: M4-23-049
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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