GE Healthcare Recalls Innova X-ray Systems for Unexpected Power Loss
GE Healthcare is recalling Innova cardiovascular X-ray systems because they may unexpectedly stop delivering X-rays, causing a loss of real-time imaging.
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: The recall involves a risk-of-harm product where the device may fail during a procedure, but the source explicitly states that no injuries have been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare, LLC is recalling specific models of Innova cardiovascular X-ray imaging systems, including the Innova 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ, and 3131IQ. The recall involves 257 units distributed worldwide, including 159 in the United States and 98 outside the U.S.
The recall is due to a potential safety issue where the system can unexpectedly stop delivering X-rays after a power-on or reset cycle. This malfunction may result in the loss of real-time interventional imaging during procedures. The affected systems are those with X-ray generators installed with Rotor V3 version and Heater V4 version boards.
No injuries have been reported due to this issue. Healthcare facilities should contact GE Healthcare to arrange for the necessary corrective actions to address the defect.
The recalled product
- Product
- GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is in
- Manufacturer
- GE Healthcare, LLC
Distribution
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