Lower riskMedical device recall · FDA · Published August 6, 2021
Philips Affiniti Ultrasound Systems Software 5.0-5.0.2 Recall: Lock-up During Exams
Philips recalls Affiniti Diagnostic Ultrasound Systems with software versions 5.0, 5.0.1, and 5.0.2 due to intermittent lock-ups during exams. Affected models include Affiniti 30, 50, and 70 series with specific serial numbers. No action is required for users but they should check their software version.
Philips is recalling Affiniti Diagnostic Ultrasound Systems with software versions 5.0, 5.0.1, and 5.0.2 because of a software defect that can cause the system to lock up while performing exams. This issue does not pose a safety risk but may disrupt medical procedures. Users should check their software version and contact Philips if needed. Read more at govinfonow.com/recall/62041-philips-affiniti-ultrasound-systems-software-5-0-5-0-2.
“Philips Affiniti Ultrasound Systems Software 5.0-5.0.2 Recall: Lock-up During Exams.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/62041-philips-affiniti-ultrasound-systems-software-5-0-5-0-2. Based on FDA recall #Z-2484-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2484-2021%22&limit=1).
The FDA has completed a voluntary Class II recall of Philips Ultrasound Affiniti Diagnostic Ultrasound Systems with software versions 5.0, 5.0.1, and 5.0.2.
How to tell if you have it
Affiniti 30
Affiniti 70
The hazard
The provided text does not specify a hazard or safety risk associated with this recall.
Context
Philips Ultrasound, Inc has 14 other recalls on record since 2019-04-29. Recent related recalls include the Philips OMNI III TEE Ultrasound Transducer (2025-09-05), Philips Ultrasound C10-3v Transducer Probe (2025-07-03), and Philips S7-3t Transducer (2025-05-28).
How to tell if you have this one
Check if your system has software versions 5.0, 5.0.1, or 5.0.2. Affected models include Affiniti 30, 50, and 70 series with specific serial numbers listed in the recall notice.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Completed
Distribution
Worldwide distribution - U.S. Nationwide distribution 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, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Albania, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Brazil, Brunei Darussalam, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Germany, Gibraltar, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Virgin Island, Yemen and Zambia.
Review your system's software version to see if it is 5.0, 5.0.1, or 5.0.2.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 49 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution 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, Puerto Rico,…” 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, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2484-2021 (August 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2484-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.