Class 2 Device Recall 5000 Compact Series Ultrasound Systems

• Date Initiated by Firm: March 23, 2024
• Date Posted: May 03, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1757-2024
• Recall Event ID: 94328
• 510(K)Number: K222648
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come with multiport adapters.
• Code Information: All Compact 5000 series systems manufactured on or before 20-Dec-2023 and purchased with Deluxe and Premium Cart options. REF/UDI-DI/Serial Numbers: 505500 CV/795141/00884838116566/USN23P0684, USN23P0623, USN23P0624, USN23P0685, USN23P0720, USN23P0615, USN23P0627, USN23P0611, USN23P0683, USN23P0682, USN23P0625, USN23P0173, USN23P0164, US823P0231, USN23P0613, USN23P0172, USN23P0721, USN23P0410, USN23P0612, USN23P0614, USN23P0171, US623P0141, US823P0233, US423P0844, US523P1060, US523P1061, US523P1750, US523P2536, US523P2537, US523P2672, US523P2673, US423P0842, US623P0140, US423P0759, US623P0142, US623P0230, US623P0485, US623P0486, US623P0740, US623P0790, US623P0791, US623P0792, US623P0866, US623P0867, US423P0843, US623P0966, US423P0672, US423P0673, US423P0674, US423P0712, US423P0757, US823P0132, US823P0232, US823P0318, US823P0319, US823P0320, US823P0321, US823P0322, US823P0507, US823P0508, US823P1857, US923P1161, US823P0129, US723P1919, US623P1072, US623P1403, US623P1483, US623P1606, US623P1607, US623P1608, US623P1609, US823P0131, US823P0029, US823P0128, US823P0127, US823P0033, US823P0032, US823P0030, US823P0028, US723P2256, US723P2154, US723P2153, US723P2152, US823P0130, US823P0031, USO23P2173, USO23P2065, US723P1242, US723P1243, US723P1342, US723P1343, US723P1241, US723P1240, USN23P0333, USN23P0332, US623P1450, US723P1766, USO23P0157, USO23P0156, USO23P0059, USO23P0058, US823P1743, US823P1744, US823P1745, US723P1582, US723P1872, US723P1583, USO23P2274, USO23P2064, USO23P2171, US623P1739, US723P1239, US723P1111, USN23P0330, USN23P0331, US923P0205, USN23P0051, US823P1767, US923P0207, US823P1770, US823P1769, US823P1251, US823P1229, US723P0393, US923P0421, USO23P2069; 5500 P/795143/00884838116573/USN23P0048, USN23P0050, USO23P2276, USO23P2275, US523P2372, US523P2538, US523P2406, US523P2405, US523P2374, US523P2373, US523P1837, US523P1838, US623P0741, US523P1839, US823P0744, US823P0745, US723P2257, US823P1030, US823P0877, US823P0548, US823P0547, US823P0546, US823P0511, US823P0509, US823P0317, US723P2258, US823P0510, US623P1486, US623P1485, US623P1741, US623P0969, US623P0968, US723P0809, US823P2055, US823P2054, US723P1584, US723P1472, US723P1471, USN23P0334, US823P2053, US723P1917, US923P0381, US823P1254, US723P0182, US723P0063, US623P2118, USO23P0171, US723P1918, US823P1250, USO23P2174, US723P0171, US723P0172, US623P2117, US723P0061, US723P0062, US723P0170, USN23P0753, US723P1809. US922P0888. US723P0596, US623P1738, US723P1112, US723P1113, US723P1767; 5500 W/795144/00884838116580/USN23P0628, USN23P0411, USN23P0174, USN23P0166, US523P2404, US623P0603, US623P0601, US423P0994, US423P0993, US423P0995, US623P0602, US623P2004, US623P1075, US723P0174, US723P0173, US623P2109, US623P2005, US922P0887, US623P1740; 5500 G/795145/00884838116597/USN23P0165, USN23P0053, USO23P1901, USO23P2068, USN23P0686, USN23P0414, USN23P0413, USN23P0412, USN23P0335, US523P2674, US523P2800, US523P2798, US523P2799, US623P0318, US623P0395, US623P0394, US623P0393, US623P0319, US623P0229, US623P0228, US623P0019, US623P0018, US623P0017, US623P0320, US523P2152, US523P2151, US523P2014, US523P2013, US523P2012, US523P1749, US523P1440, US523P1439, US823P0984, US823P0742, US823P0743, US823P0730, US823P0879, US823P1084, US823P0550, US823P0512, US823P0732, US723P2261, US723P2260, US723P2259, US623P1281, US623P1610, US623P1404, US623P1280, US623P1713, US823P0549, US823P1853, US823P1855, US823P1856, US823P1854, US723P1473, US723P1474, US723P1344, US723P1346, US723P1345, US723P1475, US823P1676, US823P0505, US723P2155, US723P2156, US823P1652, USN23P0626, US823P1678, US723P2157, USN23P0170, US723P1765, US623P2119, US823P1230, US723P0183, USO23P0172, USO23P0173, USO23P0174, US823P1677, US723P1763, US723P0064, US823P1747, US823P1746, US823P0741, USO23P2175, US723P1585, US923P0204, US723P0390, US723P0185, US723P0184, US723P0391, US723P0259, US723P0186, US723P0392, US723P0260, US723P0258, US723P0257, US723P0256, US923P0419, USN23P0049, US423P0714, US523P0946, US223P0651, US723P0599, US723P0598, US723P0597, US823P0880, US223P0650, US623P1863, US623P1864, USO23P2279, US723P1114, US723P1115, US723P1914, US723P1915, US723P1916, US623P2000, USO23P1805, US823P1768, USO23P2277, US823P2052, US723P0743, US723P0744, US823P2051, US723P0993, US723P0992, US923P0206, US823P1232, US923P0420, US723P1764, US823P1231, US923P0208; 5300 W/795146/00884838116603/US922P0893, USN23P0616, USN23P0177; 5300 P/795147/00884838116610/USN23P0724, US922P0892, USN23P0415, US723P0850, US823P0836, US723P0810, US623P0908, US623P2124, US623P2123; 5300 G/795148/00884838116627/US922P0891, US823P0230, US823P0228, US623P0484, US823P0229, USO23P2070, USO23P2176, US723P1586, USN23P0175, USN23P0176, US723P0600, USN23P0052
• Recalling Firm/ Manufacturer: Philips Ultrasound, Inc.; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Philips Customer Care Solutions Center; 800-722-9377
• Manufacturer Reason for Recall: Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns
• FDA Determined Cause: Component change control
• Action: On 3/23/24, correction notices were distributed to customers who were advised of the following two ways to avoid the condition: Option 1: To prevent the issue from occurring, when using the TEE transducers, connect directly to the Compact 5000 system using the port on the side of the system as shown in Figure 3 below. The issue is associated with the MPA, therefore by using the port on the Compact 5000 directly, the issue is avoided. Option 2: Whenever adding a transducer to, or removing a transducer from the MPA, disconnect and reconnect the MPA connector on the Compact 5000 system connector port, followed by a transducer selection on the touch screen. By performing this step when adding or removing a transducer, the monitoring and control systems are re-initialized. Circulate this URGENT Medical Device Correction Letter to all users of this device within your organization and forward to any organization where potentially affected devices have been transferred so that they are aware of the issue. In addition, customers were asked to complete and return the response form ultrasound.corrections@philips.com A firm representative will contact you to schedule a time for a Field Service Engineer to visit and implement the solution to resolve the issue For further information or support concerning this issue, please contact your local firm representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).
• Quantity in Commerce: 363
• Distribution: Worldwide - US Nationwide distribution including in the states of CA, CO, CT, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, NC, NH, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA and the countries of Australia, Austria, Bahrain, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Lithuania, Netherlands, New Zealand, Oman, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United Arab Emirates.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYN