EPIQ CVxi Diagnostic Ultrasound Systems recall: Software Issue
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Why was EPIQ CVxi Diagnostic Ultrasound Systems recalled?
Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided TEE with EchoNavigator, if secondary screen capture is enabled and user presses other system buttons before secondary capture completed.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Versions: 6.0, 7.0, 7.0.3
- Product
- EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
- Recalling firm
- Philips Ultrasound Inc
- Quantity
- 107
- Distribution
- US: MI, AZ, IA, TN, OH, CO, WI, NY, NJ, NC, LA, IL, CA, KY, IN, MD, TX, PA. OUS: Denmark, Latvia, Belgium, Hungary, Argentina, Canada, Spain, Germany, Greece, Korea, Republic of Japan, France, Australia, Egypt, Switzerland, Italy, Senegal, Israel, Indonesia, Netherlands, Hong Kong, United Kingdom, Poland, Finland, India, New Zealand
- Recall date
- October 27, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)