GE Healthcare Recalls LOGIQ S8 Ultrasound Systems for Measurement Errors
GE Healthcare is recalling 755 LOGIQ S8 Ultrasound Systems due to a software issue that may cause incorrect image measurements in Virtual Convex mode.
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 hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
GE Healthcare, LLC is recalling 755 units of the LOGIQ S8 Ultrasound System. The recall was initiated after the company internally identified a potential issue related to incorrect image measurements associated with the system's software.
The defect may cause the system to display incorrect image measurement results for Pulsed Wave (PW), Time Intensity Curve (TIC), or depth measurements when using Virtual Convex mode and placing a cursor. The affected devices were distributed worldwide, including nationwide in the United States and in numerous international countries.
Users of the affected systems should contact GE Healthcare for instructions on how to resolve the software issue. The specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 755
Distribution
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