Philips recalls EPIQ and Affiniti ultrasound systems with software version 4.0 due to potential patient folder mix-ups during editing. Affected models include EPIQ 5G, EPIC 5C, and others. No immediate action needed but software update recommended.
There is a potential that the image of one patient could get unexpectedly moved into another patient's folder when the user is using the Edit functionality on the Patient Data Entry (PDE) screen of the device.
Philips is recalling several ultrasound systems with software version 4.0 because editing patient data could accidentally move one patient's folder into another's. This might cause confusion in medical records but does not pose a direct safety risk to patients or users.
The software could accidentally switch patient folders when editing data on the Patient Data Entry screen. This might lead to incorrect patient information being associated with the wrong person during medical procedures, but it does not cause physical harm.
Healthcare providers using Philips EPIQ or Affiniti ultrasound systems with software version 4.0 are most at risk. Patients are not directly affected as the issue is a data management problem, not a physical hazard.
Check if your ultrasound system has software version 4.0. Affected models include EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70.
Verify your ultrasound system's software version. If it is 4.0, it is affected.
Contact Philips to update to a newer software version that fixes the folder mix-up issue.
No, the issue is a data management problem that might cause confusion in patient records but does not pose a physical safety risk.
No, the system can be used safely with the software update. Immediate action is not required.
Affected models include EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70 with software version 4.0.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2199-2019 — Philips Philips Hello, I own a Philips that is covered by recall Z-2199-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
