FDA announces recall of ultrasound systems impacted by software glitch

A group of ultrasound systems was the subject of a U.S. Food and Drug Administration recall last week due to a software-related issue. 

The recall applies to GE Medical Systems’ LOGIQ P9 and P10 series with software version R4.5.7. Model numbers 5877533, 5877534 and 5877535 are all affected. The recall was issued due to the potential for a software glitch to render inaccurate measurements of the liver, which could lead to misdiagnosis and/or treatment. 

“The ultrasound-guided attenuation parameter measurement data may display inaccurate values representing liver steatosis,” the FDA’s notice reads. “This could potentially lead to inappropriate clinical decisions impacting overall care.” 

GE Medical Systems became aware of the issue in September. This prompted the company to send Urgent Medical Device Correction letters to affected customers mid-month. The letter directed LOGIQ P9 and P10 users to stop using the feature if their device operates using the specified software version. GE recommends users do this until a correction can be made, which they advise will be done by a GE representative at no additional cost. Affected customers may continue to use the systems’ other features in the meantime.

The units are in operation throughout the U.S. and internationally. GE asks that organizations operating these systems post notices in areas where staff frequently use the equipment. Users who need to arrange for the correction can contact either GE HealthCare Service directly at 800-437-1171, or through their local service representative. 

The FDA’s notice indicates this is a Class 2 recall. This category of recall suggests that there is the potential for patient harm or serious health consequences, though the risks are not considered life-threatening in nature. 

Read more about the specifics here.