Philips recalls EPIQ and Affiniti ultrasound systems with certain software versions due to potential incorrect patient data display and saving. Affected models include EPIQ 5G, EPIQ 7G, Affiniti 30, 50, and 70. No immediate action required but check software versions.
The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue(s) manifest differently for different versions of software.
Philips is recalling all EPIQ and Affiniti ultrasound systems with specific software versions because they may display and save incorrect patient data during certain uncommon workflows. This could lead to misdiagnosis if the data is used for treatment decisions.
The issue occurs with certain uncommon workflows where the ultrasound system might display and save incorrect patient data. This could lead to misdiagnosis if the saved data is used for treatment decisions, but it does not happen in normal use.
Healthcare providers using Philips EPIQ or Affiniti ultrasound systems with affected software versions are most at risk. Patients using these systems for diagnostic imaging may also be impacted if incorrect data is saved.
Check if your system is listed in the recall: EPIQ 5G, EPIQ 7G, Affiniti 30, 50, or 70 models with software versions 1.0 through 5.0.1. The recall covers all EPIQ and Affiniti ultrasound systems with these specific software versions.
Verify your system's software version by checking the device settings or documentation. Affected versions include 1.0, 1.1.x, 1.2.x, 1.3.x, 1.4.x, 1.5.x, 1.8.x, 2.0.x, 3.0.x, 4.0.x, 5.0, and 5.0.1.
No, the recall does not require immediate discontinuation. The issue only occurs with certain uncommon workflows and does not affect normal use.
Affected software versions include 1.0, 1.1.x, 1.2.x, 1.3.x, 1.4.x, 1.5.x, 1.8.x, 2.0.x, 3.0.x, 4.0.x, 5.0, and 5.0.1.
Check if your system is listed in the recall: EPIQ 5G, EPIQ 7G, Affiniti 30, 50, or 70 models with the affected software versions.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0864-2021 — Philips Philips Hello, I own a Philips that is covered by recall Z-0864-2021 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.
