Terminated

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.

FDA Recall Z-0947-2021 · Posted None

Recalling FirmPhilips Ultrasound Inc

Recall StatusTerminated

Product CodeIYN

Date Initiated2020-12-24

Date Terminated2023-03-21

Product Quantity12,080 systems

Reason for Recall

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.

Firm Action

On 12/24/2020, the firm sent an "URGENT Medical Device Correction" Letter via certified mail to customers informing them that it has been detected 1 to 4 missing or loose screws on the base of the control panel arm and there is a potential for the arm to break and collapse if pressure is applied while adjusting or moving the control panel. Customers are instructed: WHEN USING THE SYSTEM: - Do not apply downward force on the Ultrasound system cart or control panel when the control arm is locked or in the lowest position. This includes leaning/bracing yourself with the system, such as when reaching across the system to the patient. WHEN POSITIONING THE SYSTEM: - Appropriately position the control panel next to the patient for better ergonomic rather than over the patient during scanning procedures. - When adjusting heights of bed rails and/or stretchers confirm all are clear of the control panel to avoid excessive load. WHEN TRANSPORTING THE SYSTEM: - Do not make any twisting or jerking motions with the control panel when adjusting or steering the system. - When transporting the system, push the system from behind using the back handles on control panel. When starting to move the system or stopping movement of the system avoid sudden downward pressure on the control panel. Customer are also instructed to complete the reply form and return to the Recalling Firm as soon as possible via email to [email protected] or fax to 1-833-512-7756. The Recalling Firm will be solving the issue by inspecting and correcting as needed all the affected systems at no cost. For questions, additional information, or support concerning this recall issue, contact the local Recalling Firm Representative at 1-800-722-9377.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2018-11-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.