The Recall Desk
ModerateFDA (Devices)·Z-1944-2013·Announced 2013-08-21

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.

What this means for you

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 Vasc
Manufacturer
GE Healthcare, LLC
Affected units
755

Distribution

Distributed nationwide across the United States.

The notice also names 32 states specifically: