GE Healthcare Recalls Innova 2121IQ and 3131IQ X-ray Systems
GE Healthcare is recalling Innova 2121IQ and 3131IQ systems due to a potential loss of imaging mode requiring a restart.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a loss of imaging functionality requiring a restart, which is a functional defect rather than a direct physical injury or contamination risk, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
GE Healthcare, LLC is recalling the Innova 2121IQ and Innova 3131IQ Cardiovascular X-ray imaging systems. The recall involves 240 units, with 133 distributed in the United States and 107 distributed outside the U.S. The systems were distributed worldwide to numerous countries including Canada, the United Kingdom, Germany, and Japan.
The recall was initiated because of a potential safety issue where the systems may lose usable imaging mode during a fluoroscopic acquisition. If this occurs, the system requires a restart to recover functionality. This issue affects the ability to generate fluoroscopic images for vascular angiography, diagnostic, and interventional procedures.
Healthcare facilities using these devices should contact GE Healthcare for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Imaging Systems
- Hazard
Distribution
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