Philips EPIQ and Affiniti Ultrasound Systems with Software 4.0: Patient Folder Mix-Up Risk
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.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/68007-philips-epiq-and-affiniti-ultrasound-systems-with-software-4-0.
Source Summary by GovInfoNow · govinfonow.com/recall/68007-philips-epiq-and-affiniti-ultrasound-systems-with-software-4-0 · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2199-2019
Cite this page
“Philips EPIQ and Affiniti Ultrasound Systems with Software 4.0: Patient Folder Mix-Up Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68007-philips-epiq-and-affiniti-ultrasound-systems-with-software-4-0. Based on FDA recall #Z-2199-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2199-2019%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Philips- Category
Medical device
What to do — step by step
Check Software Version
Verify your ultrasound system's software version. If it is 4.0, it is affected.
Update Software
Contact Philips to update to a newer software version that fixes the folder mix-up issue.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Chile,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2199-2019 (April 29, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2199-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.