GE Vivid E9 Ultrasound System Recalled for Probe Overheating Risk
GE Healthcare is recalling Vivid E9 Ultrasound Systems because incorrect power settings for four specific probe types may cause them to overheat.
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 (potential overheating) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
GE Healthcare, LLC is recalling the GE Vivid E9 Ultrasound System, a general-purpose ultrasound system specialized for cardiac imaging. The recall involves 447 units, with 81 units distributed in the United States and 366 units distributed outside the U.S. The affected units are distributed across various U.S. states and numerous international countries.
The recall is due to a potential safety issue where the probe power surveillance settings for four specific probe types (C1-5-D, C2-9-D, IC5-9-D, and M5Sc-D) are incorrect. This error may result in a situation where the probes can overheat. The source text does not report any injuries or illnesses associated with this defect.
Healthcare facilities and users should check their equipment against the list of affected serial numbers provided in the official recall notice. If a system is affected, users should contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
- Manufacturer
- GE Healthcare, LLC
- Hazard
Distribution
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