GE Healthcare Recalls innova 3100 Mobile X-ray Systems Due to Filter Failure
GE Healthcare is recalling 199 innova 3100 mobile X-ray systems due to a potential failure of the spectral filter mechanism inside the collimator.
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 is classified as FDA Class II. The hazard involves a mechanical failure in a medical device used for imaging, which poses a risk of harm or incorrect diagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling 199 units of the innova 3100 Mobile X-ray system. These systems are indicated for generating fluoroscopic images of human anatomy for various diagnostic and interventional procedures. The recall is due to a potential failure of the spectral filter mechanism inside the collimator.
The affected units are distributed nationwide. The specific model number for the recalled units is 5892935G052G. The source text does not specify the exact actions consumers or healthcare facilities should take, such as whether to stop using the devices immediately or contact the manufacturer for repair instructions.
The recalled product
- Product
- GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also…
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 199
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model number 5892935G052G
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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