GE Healthcare recalls innova mobile X-ray systems due to filter failure
GE Healthcare is recalling 199 innova mobile X-ray systems in the US 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, and the source text does not report any illnesses or injuries, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 199 units of the innova 3131-IQ Mobile X-ray system in the United States. The recall also covers the innova 3100 and innova 3100-IQ systems. These devices are indicated for generating fluoroscopic images of human anatomy for various diagnostic and interventional procedures.
The recall was initiated after it was discovered that there is a potential failure of the spectral filter mechanism inside the collimator of the affected systems. The source text does not specify the exact consequences of this failure or report any specific injuries or illnesses.
The affected units were distributed nationwide. The specific model number for the innova 3131-IQ system is 5892935G052G. The source text does not provide specific instructions for consumers or healthcare providers on how to proceed with the recall.
The recalled product
- Product
- GE Healthcare innova 3131-IQ 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…
- 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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