The Recall Desk
HighFDA (Devices)·Z-0123-2022·Announced 2021-10-27

Philips EPIQ CVxi Ultrasound Systems Software Issue Causes System Unresponsiveness

Philips EPIQ CVxi ultrasound systems running software versions 6.0, 7.0, or 7.0.3 may become unresponsive due to an EchoNavigator error, requiring system restart that could delay treatment.

What this means for you

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: This is an FDA Class II medical device recall with no reported injuries or illnesses. The hazard is functional—system unresponsiveness—that creates a risk of harm through treatment delay. Since harm has not yet been reported and the hazard is operational rather than confirmed, the score is at most 3 per the rubric.

Plain-English summary

Philips Ultrasound Inc. has recalled 107 EPIQ CVxi Diagnostic Ultrasound Systems (Product Code 795232) running software versions 6.0, 7.0, or 7.0.3. A software issue can trigger an EchoNavigator error notification and render the system unresponsive during operation.

The condition occurs when EchoNavigator is enabled during transesophageal echocardiography (TEE) and the user presses system buttons before the secondary screen capture is completed. When unresponsive, the system requires a manual restart. Such a restart could result in treatment delay or potentially lead to unnecessary treatment being performed.

The recalled units are distributed across the United States, including Michigan, Arizona, Iowa, Tennessee, Ohio, Colorado, Wisconsin, New York, New Jersey, North Carolina, Louisiana, Illinois, California, Kentucky, Indiana, Maryland, Texas, and Pennsylvania. International distribution includes Denmark, Latvia, Belgium, Hungary, Argentina, Canada, Spain, Germany, Greece, Korea, Japan, France, Australia, Egypt, Switzerland, Italy, Senegal, Israel, Indonesia, Netherlands, Hong Kong, United Kingdom, Poland, Finland, India, and New Zealand.

Facilities operating these systems should contact Philips Ultrasound Inc. for information regarding software updates or other remediation options.

The recalled product

Product
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Manufacturer
Philips Ultrasound Inc
Category
Medical Device — Diagnostic Ultrasound
Hazard
  • system-malfunction
  • treatment-delay
  • software-error

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 (3)

  • Software Versions: 6.0
  • 7.0
  • 7.0.3

Distribution

Distributed in 18 states:

  • AZ
  • CA
  • CO
  • IA
  • IL
  • IN
  • KY
  • LA
  • MD
  • MI
  • NC
  • NJ
  • NY
  • OH
  • PA
  • TN
  • TX
  • WI

Related recalls

Same category