GE Healthcare Recalls Cardiovascular X-ray Systems Due to Locking Nut Issue
GE Healthcare is recalling specific cardiovascular X-ray imaging systems because a locking nut on the overhead video monitor suspension might loosen.
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: The recall involves a mechanical defect in a medical device that could result in the video monitor suspension failing, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling specific models of Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems. The recall involves 297 units distributed worldwide, including in the United States and numerous international locations.
The recall is being conducted because a locking nut might loosen out of the overhead Video Monitor Suspension yoke. This defect could affect the stability of the video monitor suspension on the affected imaging systems.
The source text does not specify reported injuries or illnesses associated with this defect. Users of these systems should contact GE Healthcare for instructions on how to address the issue.
The recalled product
- Product
- GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 297
Distribution
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