GE Healthcare Recalls innova 3100-IQ Mobile X-ray Systems Due to Filter Failure
GE Healthcare is recalling 199 innova 3100-IQ mobile X-ray systems in the US due to a potential failure of the spectral filter mechanism inside the collimator.
What this means for you
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 hazard involves a potential mechanical failure in a medical device used for diagnostic and interventional procedures. No injuries or illnesses are reported in the source text, placing it in the 'High' category 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 3100-IQ Mobile X-ray system in the United States. The recall is due to a potential failure of the spectral filter mechanism located inside the collimator of the device.
The innova 3100-IQ 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 indicated for generating fluoroscopic images for cardiology, diagnostic, and interventional procedures.
The affected units are distributed nationwide. The specific model number for the recalled units is 5892935G052G. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.
The recalled product
- Product
- GE Healthcare innova 3100-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 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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