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.
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 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…
- Manufacturer
- GE Healthcare, LLC
Distribution
Related recalls
Same manufacturer · GE Healthcare, LLC
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
- HighGE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
- SevereGE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighGE Healthcare Recalls Cardiovascular X-ray Systems Due to Exposed Wires
FDA (Devices) · 2013-03-20
- HighGE Healthcare Recalls Innova 2100IQ Angiographic X-ray Systems
FDA (Devices) · 2015-07-08
- HighGE Healthcare recalls innova mobile X-ray systems due to filter failure
FDA (Devices) · 2012-10-31
- HighGE Healthcare Recalls Innova Fluoroscopic Systems Due to Relay Failure
FDA (Devices) · 2013-05-22
- ModerateGE Healthcare Recalls Innova 2121IQ and 3131IQ X-ray Systems
FDA (Devices) · 2012-09-19
- HighGE Healthcare Recalls innova 3100-IQ Mobile X-ray Systems Due to Filter Failure
FDA (Devices) · 2012-10-31