GE Healthcare Recalls Innova IGS 630 Biplane Imaging Systems
GE Healthcare is recalling 28 Innova IGS 630 biplane imaging systems because a specific user action may cause the X-ray function to lock up.
What this means for you
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 system lock-up that could interrupt imaging, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
GE Healthcare, LLC is recalling 28 units of the Innova IGS 630 Biplane Cardiovascular and Interventional Imaging System. The recall covers 12 units in the United States and 16 units in other countries. The affected systems are distributed in the US states of California, Colorado, Florida, Nevada, New Jersey, Pennsylvania, and Texas, as well as in the Czech Republic, France, Japan, Republic of Korea, Saudi Arabia, and Turkey.
The recall is due to a potential safety issue where the X-ray imaging function may be lost if a user changes the size of the lateral Field of View (FOV) and releases the biplane footswitch pedal simultaneously. This specific combination of actions could lead to a system lock-up. The source text does not report any injuries or illnesses associated with this issue.
Healthcare facilities that have these systems should contact GE Healthcare for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascu
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Imaging System
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
- HighSIGNA Premier MRI scanner recalled for elevated acoustic noise hazard
FDA (Devices) · 2022-07-27
Same hazard · system lockup
See all →- HighPhilips Affiniti Ultrasound Systems Recalled for Software Lock-Up During Exams
FDA (Devices) · 2021-09-29
- HighSiemens Sensis Vibe Systems Recalled for Potential System Freezes
FDA (Devices) · 2021-03-10
- HighPhilips Recalls Velara Generators Due to Potential System Lockup
FDA (Devices) · 2017-02-01
- HighPhilips Velara Generator Recall for System Lockup Risk
FDA (Devices) · 2017-02-01
- ModerateSiemens ACUSON X700 Ultrasound System Recalled for Software Lockup
FDA (Devices) · 2016-05-04