GE Healthcare Recalls Innova 3100 and 4100 Fluoroscopic Systems
GE Healthcare is recalling Innova 3100 and 4100 systems due to a potential safety issue involving temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration.
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 source text describes a 'potential safety issue' involving temporary loss of imaging modes but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
GE Healthcare, LLC is recalling 48 units of the Innova 3100 and Innova 4100 Digital Fluoroscopic Imaging Systems. These systems are indicated for use in diagnostic and interventional angiographic procedures of human anatomy and are intended to replace image intensifier fluoroscopic systems.
The recall is due to a potential safety issue where the systems may experience a temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration. The affected units were distributed worldwide, including in the United States (AZ, CA, CO, FL, ID, IL, ME, NV, NY, NC, OK, TN, UT, and WI) and internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway, and Spain.
Healthcare facilities should contact GE Healthcare for instructions on how to address the issue. Specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or…
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 48
Distribution
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