Recall record at a glance
| Official record | Z-0947-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Philips Ultrasound Inc. |
| Report date | Feb 10, 2021 |
| Recall initiation date | Dec 24, 2020 |
| Quantity | 12,080 systems |
| Location | Bothell, WA, United States |
Official product description
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.
Why the product was recalled
Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off.
Distribution information
Worldwide distribution - US Nationwide, Puerto Rico, and Virgin Islands. O.U.S.: AE - United Arab Emirates AL - Albania AM - Armenia AR - Argentina AT - Austria AU - Australia AZ - Azerbaijan BA - Bosnia BD - Bangladesh BE - Belgium BG - Bulgaria BH - Bahrain BN - Brunei BO - Bolivia BR - Brazil BY - Belarus CA - Canada CH - Switzerland CL - Chile CN - China CO Colombia CR Costa Rica CY - Cyprus CZ Czech Republic DE - Germany DK - Denmark DO Dominican Republic DZ - Algeria EC - Ecuador EE - Estonia EG - Egypt ES - Spain ET - Ethiopia FI - Fiji FR - France GB United Kingdom GF French Guiana GP - Guadeloupe GR - Greece GT - Guatemala HK Hong Kong HN - Honduras HR - Croatia HU - Hungary ID - Indonesia IE - Ireland IL - Israel IN - India IR - Iran IT - Italy JO - Jordan JP - Japan KE - Kenya KH - Cambodia KR South Korea KW - Kuwait KZ - Kazakhstan LB - Lebanon LK Sri Lanka LT - Lithuania LU - Luxembourg LV - Latvia LY - Libyan MA - Morocco MC - Monaco MD Republic of Moldova ME - Montenegro MM - Myanmar MO - Macau MQ - Martinique MT - Malta MU Mauritius MX Mexico MY Malaysia NC New Caledonia NI - Nicaragua NL - Netherlands NO - Norway NZ New Zealand OM - Oman PA - Panama PE - Peru PF French Polynesia PH - Philippines PK - Pakistan PL - Poland PS - Palestinian PT - Portugal QA - Qatar RE - Reunion RO - Romania RS - Serbia RU - Russia SA Saudi Arabia SE - Sweden SG - Singapore SI - Slovenia SK - Slovakia TH - Thailand TM - Turkmenistan TN - Tunisia TR - Turkey TT - Trinidad TW - Taiwan UA - Ukraine UY - Uruguay UZ - Uzbekistan VN - Vietnam ZA South Africa
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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