GE Healthcare Recalls Optima CL323i and IGS 320 X-ray Systems
GE Healthcare is recalling 108 Optima CL323i and Optima IGS 320 angiographic X-ray systems due to a potential loss of displayed imaging.
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 loss of critical imaging data during medical procedures, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
GE Medical Systems, LLC is recalling 108 units of the Optima CL323i and Optima IGS 320 angiographic X-ray systems. These systems are used to generate fluoroscopic and rotational images of human anatomy for various diagnostic and interventional procedures.
The recall is due to a potential safety issue involving a non-recoverable loss of displayed imaging, specifically a loss of monitor video. This issue could affect the ability to view images during procedures.
The affected units were distributed worldwide, including in the United States and numerous international countries. Healthcare facilities should contact GE Healthcare for further instructions regarding the recall and remediation of the affected systems.
The recalled product
- Product
- GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and intervention
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 108
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Medical Systems, 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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