Philips recalls EPIQ Elite, 5G, 5C, 7G, 7C, CVx & CVxi ultrasound systems due to Image Boost feature causing inaccurate blood flow visualization in certain transducers.
The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled the color box shows flow visualization not accurately represent the fluid flow. Similarly, if Image Boost is enabled, both CW and PW Doppler traces will not accurately represent the fluid flow.
Philips is recalling several EPIQ ultrasound systems because the Image Boost feature can show inaccurate blood flow when used with specific transducers. This could lead to incorrect medical diagnoses if the ultrasound technician relies on the inaccurate flow visualization.
When the Image Boost feature is enabled on the ultrasound system, the color flow visualization and Doppler traces may not accurately show blood flow. This could lead to incorrect medical interpretations if the technician relies on the inaccurate flow visualization.
Medical professionals using Philips EPIQ ultrasound systems with the EPIQ Elite, 5G, 5C, 7G, 7C, CVx, or CVxi models are most at risk. The issue affects the accuracy of blood flow visualization when using the X8-2t TEE transducer with Image Boost enabled.
Check if your Philips EPIQ ultrasound system has model numbers EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx, or EPIQ CVxi. The issue occurs when using the X8-2t TEE transducer with Image Boost enabled.
Ensure Image Boost is disabled when using the X8-2t TEE transducer to prevent inaccurate blood flow visualization.
No, only specific models: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx, and EPIQ CVxi.
Disable Image Boost when using the X8-2t TEE transducer to avoid inaccurate blood flow visualization.
The recall does not mention any risk of injury; it only affects the accuracy of blood flow visualization.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0944-2021 — Philips Philips Hello, I own a Philips that is covered by recall Z-0944-2021 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.