GE Precision MPi X-ray System Recalled for Touch Panel Boot Issues
Regulatory Insight, Inc. is recalling 43 GE Precision MPi X-ray systems because the Remote Touch Panel may fail to boot up as intended.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Regulatory Insight, Inc. is recalling 43 units of the GE Precision MPi all-digital multipurpose tilt-C x-ray system. The recall was initiated because the Remote Touch Panel (RTP) of the system may not always boot up as intended and requires an update to properly accomplish its intended purpose.
The affected units were distributed in the United States to the states of Tennessee, California, Washington, Oregon, Pennsylvania, Wisconsin, Florida, Minnesota, Vermont, New York, Nevada, Massachusetts, Colorado, Indiana, Michigan, Mississippi, and Ohio. The product is intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
Healthcare facilities and users of the GE Precision MPi system should contact Regulatory Insight, Inc. for further instructions regarding the necessary update to the Remote Touch Panel.
The recalled product
- Product
- GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
- Manufacturer
- Regulatory Insight, Inc
- Hazard
- Affected units
- 43
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)
- NRT no.: 02980000
Distribution
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