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
Check against the official notice below — it lists the full affected range.
Philips Ultrasound Inc. is recalling approximately 12,080 EPIQ diagnostic ultrasound systems worldwide, including models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, and EPIQ CVxi. The affected systems were distributed across the United States, Puerto Rico, Virgin Islands, and numerous countries internationally. The control panel arm assembly on these systems may have missing or loose screws, which can cause the control panel mechanism to fail and break off when undue force, pressure, or weight is applied.
The recall record does not specify a remedy or recommended action for affected consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: 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 - Cypr Quantity: 12,080 systems Lot/code info: Model/System Designations: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi UDI Codes: (01)00884838088658(21)US120B0832 (01)00884838088658(21)US619B1137 (01)00884838088658(21)US720B0256 (01)00884838088658(21)US220B1203 (01)00884838088658(21)US919B0305 (01)00884838088658(21)USN19B1106 (01)00884838088658(21)US220B1587 (01)00884838088658(21)US919B1343 (01)00884838088658(21)USO19B0137 (01)00884838088658(21)USO19B2575 (01)00884838088658(21)US120B0933 (01)00884838088658(21)US619B1530 (01)00884838088658(21)US420B2445 (01)00884838088658(21)US420B2446 (01)00884838088658(21)US520B1252 (01)00884838088658(21)US520B1253 (01)00884838088658(21)US520B1254 (01)00884838088658(21)US620B2080 (01)00884838088658(21)US620B2081 (01)00884838088658(21)US620B2082 (01)00884838088658(21)US619B1796 (01)00884838088658(21)US520B0405 (01)00884838088658(21)US520B0407 (01)00884838088658(21)US520B0408 (01)00884838088658(21)US520B0404 (01)00884838088658(21)US520B0412 (01)00884838088658(21)US620B0625 (01)00884838088658(21)US620B0626 (01)00884838088658(21)US620B0627 (01)00884838088658(21)US620B0628 (01)00884838088658(21)US620B0629 (01)00884838088658(21)US620B0630 (01)00884838088658(21)US720B1295 Serial Numbers: US820C0578 US119B1417 US119B1557 US120C0464 US319B0073 US719B1853 US719B1854 USN19B2032 US819B2075 USO19B0691 USO19B1741 US619B0221 US619C0415 US220B0520 US819C0242 US719B2105 US719B2106 US819C0243 US819C1639 US819C1640 US519B0996 US619C0505 US819C0501 US820B1506 US820B
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.