Lower riskMedical device recall · FDA · Published October 27, 2020
Philips Ultrasound Systems Recall: Incorrect Patient Data Risk
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. Read more at govinfonow.com/recall/64050-philips-ultrasound-systems-recall-incorrect-patient-data-risk.
“Philips Ultrasound Systems Recall: Incorrect Patient Data Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64050-philips-ultrasound-systems-recall-incorrect-patient-data-risk. Based on FDA recall #Z-0864-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0864-2021%22&limit=1).
The FDA announced on 2020-10-27 that Philips Ultrasound Inc is recalling All EPIQ and Affiniti Ultrasound systems due to the potential for incorrect patient data to be displayed and saved. The recall affects 57,430 units distributed worldwide.
The manufacturer determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue manifests differently for different versions of software.
Context
GovInfoNow's records show Philips Ultrasound, Inc has had 14 other recalls since 2019-04-29. Recent brand recalls include the 2025-09-05 Philips OMNI II TEE Ultrasound Transducer Recall and the 2025-07-03 Philips mC12-3 Transducer Probe Recall, both addressing clarification on useful life. Other recent recalls of similar products include the 2026-08-07 Philips EPIQ Elite Ultrasound System Recall for inaccurate blood flow measurements and the 2026-07-31 GE Healthcare Enterprise Archive V8 Software Recall for patient data mismatch risk.
How to tell if you have this one
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.
Brand
Philips
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
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.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0864-2021 (October 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0864-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.