GE Healthcare Recalls Innova 2121IQ Angiographic X-ray Systems
GE Healthcare is recalling Innova 2121IQ angiographic X-ray systems due to a potential 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 risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare is recalling one unit of the Innova 2121IQ 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 is being conducted because GE Healthcare became aware of a potential safety issue that may result in the loss of C-arm gantry motion capability. This issue affects fluoroscopic interventional imaging systems, including the Innova, Optima, and Discovery lines.
The affected system is distributed worldwide, including in the United States and various international countries. The specific unit involved has Serial Number 0000011BC20026 and System ID 2192632121. No specific instructions for consumers are provided in the source text, but the recall is managed by GE Healthcare.
The recalled product
- Product
- GE Healthcare Innova 2121IQ. 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
- Hazard
- Affected units
- 1
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)
- Serial Number System ID 0000011BC20026 2192632121
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.
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