Recall record at a glance
| Official record | Z-2483-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Completed |
| Recalling firm | Philips Ultrasound Inc. |
| Report date | Sep 29, 2021 |
| Recall initiation date | Aug 6, 2021 |
| Quantity | Total = 10,583 systems (EPIQ and Afiniti) |
| Location | Bothell, WA, United States |
Official product description
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231
Why the product was recalled
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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