GE Healthcare Recalls Innova 3131IQ Angiographic X-ray Systems
GE Healthcare is recalling two Innova 3131IQ angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.
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 involves a medical device with a potential safety issue that could compromise the functionality of the imaging system during procedures. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Healthcare is recalling two units of the Innova 3131IQ angiographic X-ray system. These systems are used to generate fluoroscopic and rotational images of human anatomy for diagnostic, interventional, and image-guided surgical procedures.
The recall was initiated because GE Healthcare became aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic interventional imaging systems. The affected serial numbers are 005178429-0176 (System ID 561881BP1) and 0000010BC20004 (System ID B5114298).
The affected units were distributed worldwide, including in the United States and various international countries. Healthcare facilities and users of these specific systems should contact GE Healthcare for further instructions regarding the safety issue.
The recalled product
- Product
- GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
- Manufacturer
- GE Healthcare
- Affected units
- 2
Distribution
Part of a larger recall action
This product is one of 13 recalled by GE Healthcare 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.
See all 13 products in this recall →Related recalls
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