GE Healthcare Recalls Cardiovascular X-ray Systems Due to Exposed Wires
GE Healthcare is recalling 48 Innova IQ cardiovascular X-ray systems because exposed high-voltage wires inside the cabinet pose a shock hazard.
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 risk-of-harm product (exposed high-voltage wires) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
GE Healthcare, LLC is recalling 48 units of the Innova 2100 IQ, Innova 3100 IQ, and Innova 4100 IQ cardiovascular X-ray imaging systems. These devices are used to generate fluoroscopic images of human anatomy. The recall is due to a defect where two shrink tubings covering a 400V live cable inside the system cabinet leave an area potentially unprotected, exposing high-voltage wires.
The affected units were distributed worldwide, including in the United States (specifically Florida, Illinois, Indiana, New Jersey, North Carolina, Oklahoma, Texas, and Wisconsin) and numerous international locations such as the United Kingdom, China, and India. Specific serial numbers for the 48 affected units are listed in the official recall documentation.
No injuries or illnesses have been reported in connection with this defect. GE Healthcare is working to correct the issue. Users of these systems should contact GE Healthcare for instructions on how to resolve the hazard.
The recalled product
- Product
- GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 48
Distribution
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