—#206941

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.

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K222648
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Component change control

Action the firm took

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).

Recalling firm

Firm: Philips Ultrasound, Inc.
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-03-23
Posted by FDA: 2024-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206941. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.