GE Healthcare, LLC recalls ApexPro Telemetry Server System. Also identified as Modific

Hazard / Issue

May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 1. Product Code: 3F, No UDI Number, Serial Numbers: M13F1043G, B23F1531G, B23F1532G, B23F2216G, A23F1290G, B23F1324G, M13F1152G, M13F1153G, M13F1154G, M13F1155G, M13F1164G, M13F1165G, M13F1166G, M13F1168G, M13F1169G, L13F0687G, D23F1925G, D23F1968G, E23F2074G, E23F2075G, B23F1402G, M13F1059G, M13F1173G, M13F1109G, C23F1815G, A23F1260G, J13F0272G, C23F1607G, D23F1981G, M13F0968G, L13F0683G, L13F0576G, J13F0274G, B23F1302G, K13F0437G, C23F1793G, D23F1943G, M13F1094G, B23F1495G, K13F0481G, L13F0571G, B23F1304G, C23F1808G, D23F1899G, M13F1151G, J13F0098G, J13F0099G, J13F0100G, C23F1594G, M13F1099G, B23F1439G, J13F0229G, L13F0600G, K13F0499G, K13F0500G, K13F0501G, L13F0623G, L13F0624G, L13F0625G, B23F13886, B23F1388G, B23F1390G, D23F1851G, D23F1861G, J13F0369G, M13F1075G, M13F1084G, M13F0891G, M13F0892G, A23F1229G, E23F2036G, L13F0776G, A23F1258G, B23F1315G, B23F1496G, B23F1501G, B23F1502G, B23F1506G, B23F1508G, C23F1784G, F13F0006G, J13F0006G, L13F0864G, L13F0865G, L13F0866G, L13F0668G, 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L13F0856G, M13F1028G, C23F1760G, C23F1761G, C23F1762G, C23F1609G, C23F1613G, M13F1017G, D23F1915G, M13F1023G, M13F1004G, C23F1636G, D23F1919G, C23F1759G, D23F1840G, M13F1020G, M13F1021G, M13F1022G, M13F1024G, M13F1027G, C23F1625G, C23F1632G, C23F1633G, C23F1635G, E23F2058G, E23F2059G, C23F1763G, C23F1766G, C23F1627G, D23F2022G, E23F2063G, M13F0988G, M13F1025G, M13F1026G, D23F1916G, D23F1917G, D23F1918G, D23F1920G, D23F1921G, D23F1923G, D23F1924G, M13F0999G, M13F1000G, M13F1001G, M13F1002G, M13F1003G, E23F2053G, E23F2054G, C23F1628G, M13F1019G, E23F2051G, M13F1007G, M13F1011G, M13F1012G, C23F1629G, C23F1672G, C23F1673G, C23F1674G, C23F1676G, C23F1677G, C23F1679G, C23F1688G, C23F1705G, E23F2043G, C23F1764G, C23F1765G, E23F2070G, C23F1614G, E23F2052G, C23F1687G, C23F1704G, E23F2050G, C23F1612G, C23F1634G, F23F2044G, C23F1610G, C23F1626G, C23F1630G, B23F1511G, L13F0684G, L13F0686G, M13F0937G, D23F1834G, A23F1254G, A23F1255G, A23F1259G, A23F1261G, J13F0088G, J13F0115G, D23F1833G, C23F1621G, J13F0016G, M13F1064G, J13F0086G, D23F1983G, K13F0439G, E23F2040G, D23F1822G, D23F1823G, D23F1824G, D23F1825G, J13F0018G, L13F0619G, L13F0620G, L13F0622G, L13F0736G, L13F0784G, J13F0164G, J03F0164G, J13F0338G, L13F0847G, L13F0849G, M13F0890G, L13F0627G, L13F0643G, L13F0644G, L13F0645G, L13F0656G, L13F0657G, L13F0658G, J13F0306G, C23F1637G, C23F1638G, M13F1103G, C23F1782G, M13F0904G, M13F0905G, M13F0906G, M13F1077G, M13F1078G, M13F1079G, M13F1080G, M13F1081G, M13F1090G, M13F1091G, M13F1092G, D23F1874G, E23F2028G, K13F0467G, L13F0789G, E23F2071G, K13F0555G, J13F0172G, J13F0173G, J13F0176G, J13F0353G, J13F0068G, J13F0120G, J13F0127G, J13F0165G, J13F0371G, K13F0445G, K13F0446G, K13F0447G, C13F1620G, C23F1619G, C23F1620G, K13F0452G, K13F0453G, M13F1177G, E23F2041G, C23F1646G, C23F1730G, D23F1821G, D23F1961G, L13F0716G, B23F1416G, B23F1522G, B23F1556G, C23F1567G, D23F1906G, C23F1571G, K13F0442G, K13F0443G, K13F0444G, B23F1557G, B23F1552G, C23F1578G, C23F1579G, C23F1580G, C23F1562G, C23F1560G, C23F1569G, C23F1572G, C23F1573G, L13F0590G, L13F0591G, L13F0595G, B23F1558G, C23F1564G, C23F1566G, C23F1561G, C23F1568G, C23F1574G, B23F1550G, B23F1559G, C23F1563G, C23F1565G, C23F1570G, C23F1577G, C23F1581G, C23F1582G, C23F1583G, C23F1618G, F23F2110G, K13F0546G, K13F0547G, L13F0626G, C23F1575G, B23F1394G, C23F1702G, D23F1901G, J13F0015G, L13F0662G, C23F1669G, C23F1736G, A23F1194G, K13F0466G, M13F0913G, M13F0932G, M13F0916G, B23F1299G, A23F1193G, F23F2108G, L13F0762G, B23F1515G, B23F1520G, J13F0135G, J13F0136G, B23F1484G, C23F1661G, C23F1710G, C23F1715G, D23F1829G, D23F1830G, D23F1931G, L13F0586G, A23F1179G, L13F0601G, M13F0938G, J13F0110G, C23F1667G, A23F1204G, M13F0883, M13F0883G, M13F0883S, C23F1659G, A23F1203G, L13F0771G, A23F1268G, E23F2042G, M13F0923G, C23F1640G, C23F1641G, D23F1826G, K13F0427G, K13F0429G, K13F0434G, K13F0440G, B23F1443G, K13F0448G, B23F1413G, C23F1654G, K13F0430G, C23F1653G, L13F0765G, L13F0766G, A23F1192G, A23F1200G, J13F0111G, L13F0661G, M13F0957G, B23F1412G, L13F0816G, C23F16549, D23F1963G, A23F1205G, J13F0174G, C23F1639G; 2. Product Code: 4T, UDI Number (Serial Numbers): Not Applicable (F24T0254G), Not Applicable (F24T0259G), Not Applicable (F24T0264G), Not Applicable (F24T0279G), Not Applicable (A44T4691G), Not Applicable (A44T4713G), Not Applicable (C44T4931G), Not Applicable (D34T2574G), Not Applicable (H34T3263G), Not Applicable (H34T3264G), Not Applicable (H34T3266G), Not Applicable (H34T3267G), Not Applicable (H34T3268G), Not Applicable (H34T3270G), Not Applicable (H34T3272G), Not Applicable (H34T3274G), Not Applicable (M24T1660G), Not Applicable (M24T1661G), Not Applicable (M24T1662G), Not Applicable (M24T1672G), Not Applicable (M24T1710G), Not Applicable (M24T1716G), Not Applicable (M24T1718G), Not Applicable (M24T1721G), Not Applicable (M34T4314G), Not Applicable (M34T4315G), Not Applicable (M34T4316G), Not Applicable (M34T4321G), Not Applicable (M34T4360G), Not Applicable (M34T4368G), Not Applicable (M34T4482G), Not Applicable (M34T4215G), Not Applicable (M34T4216G), Not Applicable (J34T3725G), Not Applicable (J34T3752G), Not Applicable (J34T3755G), Not Applicable (M34T4340G), Not Applicable (G24T0384G), Not Applicable (K24T1151G), Not Applicable (L24T1274G), Not Applicable (L24T1284G), Not Applicable (L24T1377G), Not Applicable (L24T1401G), Not Applicable (L34T4001G), Not Applicable (A44T4739G), Not Applicable (G24T0475G), Not Applicable (A44T4573G), Not Applicable (C34T2261G), Not Applicable (B44T4778G), Not Applicable (F24T0081G), Not Applicable (F24T0292G), Not Applicable (F24T0294G), Not Applicable (F24T0296G), Not Applicable (F24T0297G), Not Applicable (F24T0318G), Not Applicable (F34T2928G), Not Applicable (K24T1003G), Not Applicable (L34T4174G), Not Applicable (F34T3021G), Not Applicable (C34T2336G), Not Applicable (F24T0242G), Not Applicable (L34T4041G), Not Applicable (M34T4479G), Not Applicable (F24T0084G), Not Applicable (G24T0564G), Not Applicable (M24T1736G), Not Applicable (M34T4449G), Not Applicable (M34T4450G), Not Applicable (B34T1952G), Not Applicable (A34T1762G), Not Applicable (F24T0124G), Not Applicable (F24T0241G), Not Applicable (F34T2959G), Not Applicable (J24T0609G), Not Applicable (J24T0826G), Not Applicable (K24T1143G), Not Applicable (K34T3974G), Not Applicable (M34T4381G), Not Applicable (A34T1853G), Not Applicable (B44T4800G), Not Applicable (D44T5014G), Not Applicable (K34T3833G), Not Applicable (K34T3834G), Not Applicable (K34T3837G), Not Applicable (K34T3843G), Not Applicable (K34T3858G), Not Applicable (K34T3859G), Not Applicable (K34T3966G), Not Applicable (M24T1560G), Not Applicable (M24T1665G), Not Applicable (M24T1673G), Not Applicable (M24T1692G), Not Applicable (M34T4413G), Not Applicable (M34T4415G), Not Applicable (M34T4442G), Not Applicable (M34T4443G), Not Applicable (M34T4444G), Not Applicable (M34T4445G), Not Applicable (L34T4036G), Not Applicable (C34T2256G), Not Applicable (K24T1165G), Not Applicable (L24T1309G), Not Applicable (M24T1528G), Not Applicable (C34T2324G), Not Applicable (C34T2326G), Not Applicable (C34T2328G), Not Applicable (C34T2341G), Not Applicable (A34T1825G), Not Applicable (A34T1826G), Not Applicable (A34T1827G), Not Applicable (A34T1829G), Not Applicable (A34T1830G), Not Applicable (A34T1831G), Not Applicable (A34T1832G), Not Applicable (A34T1848G), Not Applicable (A34T1896G), Not Applicable (A34T1899G), Not Applicable (A34T1900G), Not Applicable (A34T1903G), Not Applicable (B34T2033G), Not Applicable (C34T2298G), Not Applicable (C44T4984G), Not Applicable (G24T0512G), Not Applicable (J34T3789G), Not Applicable (J34T3791G), Not Applicable (C34T2275G), Not Applicable (C34T2361G), Not Applicable (C34T2365G), Not Applicable (C34T2378G), Not Applicable (F24T0247G), Not Applicable (J24T0867G), Not Applicable (J24T0873G), Not Applicable (J34T3597G), Not Applicable (J34T3598G), Not Applicable (J34T3604G), Not Applicable (J34T3605G), Not Applicable (J34T3606G), Not Applicable (J34T3628G), Not Applicable (J34T3631G), Not Applicable (J34T3669G), Not Applicable (K34T3871G), Not Applicable (F34T2927G), Not Applicable (M24T1608G), Not Applicable (M24T1647G), Not Applicable (D34T2530G), Not Applicable (D34T2534G), Not Applicable (D34T2538G), Not Applicable (J34T3517G), Not Applicable (J24T0831G), Not Applicable (C34T2265G), Not Applicable (C34T2267G), Not Applicable (F24T0269G), Not Applicable (J34T3816G), Not Applicable (B34T1947G), Not Applicable (B34T1951G), Not Applicable (J24T0846G), Not Applicable (J24T0862G), Not Applicable (J24T0876G), Not Applicable (H34T3437G), Not Applicable (A44T4581G), Not Applicable (B34T1984G), Not Applicable (B34T1989G), Not Applicable (B44T4905G), Not Applicable (B44T4913G), Not Applicable (C44T4930G), Not Applicable (F24T0054G), Not Applicable (F24T0239G), Not Applicable (G24T0414G), Not Applicable (G24T0506G), Not Applicable (G24T0520G), Not Applicable (G24T0521G), Not Applicable (G24T0524G), Not Applicable (H34T3284G), Not Applicable (J24T0738G), Not Applicable (J24T0833G), Not Applicable (J24T0836G), Not Applicable (M24T1668G), Not Applicable (M24T1671G), Not Applicable (D34T2454G), Not Applicable (D34T2535G), Not Applicable (D34T2545G), Not Applicable (F24T0053G), Not Applicable (D44T5027G), Not Applicable (K24T1117G), Not Applicable (K24T1118G), Not Applicable (K24T1190G), Not Applicable (K24T1191G), Not Applicable (K24T1196G), Not Applicable (K24T1197G), Not Applicable (K24T1200G), Not Applicable (B44T4880G), Not Applicable (B44T4882G), Not Applicable (J24T0642G), Not Applicable (J24T0813G), Not Applicable (M24T1569G), Not Applicable (B34T2021G), Not Applicable (M24T1540G), Not Applicable (J34T3601G), Not Applicable (M24T1603G), Not Applicable (M24T1749G), Not Applicable (M34T4339G), Not Applicable (M34T4493G), Not Applicable (M34T4494G), Not Applicable (K34T3968G), Not Applicable (D34T2629G), Not Applicable (B34T2006G), Not Applicable (M24T1609G), Not Applicable (M24T1663G), Not Applicable (A44T4676G), Not Applicable (B34T1991G), Not Applicable (B34T1998G), Not Applicable (B34T1999G), Not Applicable (B34T2105G), Not Applicable (B34T2107G), Not Applicable (B34T2108G), Not Applicable (B34T2109G), Not Applicable (D34T2440G), Not Applicable (H34T3419G), Not Applicable (J24T0704G), Not Applicable (J24T0790G), Not Applicable (J24T0792G), Not Applicable (J24T0799G), Not Applicable (J24T0854G), Not Applicable (J34T3807G), Not Applicable (K34T3839G), Not Applicable (K34T3840G), Not Applicable (K34T3841G), Not Applicable (K34T3844G), Not Applicable (L24T1304G), Not Applicable (F34T3027G), Not Applicable (K34T3920G), Not Applicable (L34T4102G), Not Applicable (L34T4103G), Not Applicable (L34T4104G), Not Applicable (L34T4105G), Not Applicable (L34T4106G), Not Applicable (K24T1214G), Not Applicable (K24T1215G), Not Applicable (K24T1225G), Not Applicable (L24T1362G), Not Applicable (H34T3477G), Not Applicable (K24T1266G), Not Applicable (L34T4005G), Not Applicable (M24T1455G), Not Applicable (F34T2841G), Not Applicable (M34T4432G), Not Applicable (F24T0308G), Not Applicable (F24T0309G), Not Applicable (G24T0417G), Not Applicable (G24T0420G), Not Applicable (J34T3521G), Not Applicable (G24T0462G), Not Applicable (G24T0470G), Not Applicable (B34T1979G), Not Applicable (B34T1986G), Not Applicable (B34T1987G), Not Applicable (L24T1294G), Not Applicable (L24T1303G), Not Applicable (L24T1315G), Not Applicable (H34T3361G), Not Applicable (K24T1193G), Not Applicable (K24T1198G), Not Applicable (B34T2043G), Not Applicable (B34T2047G), Not Applicable (B34T2055G), Not Applicable (B34T2202G), Not Applicable (L24T1391G), Not Applicable (F24T0278G), Not Applicable (F24T0149G), Not Applicable (F24T0211G), Not Applicable (G24T0324G), Not Applicable (H34T3435G), Not Applicable (M24T1512G), Not Applicable (J24T0900G), Not Applicable (L34T4109G), Not Applicable (M34T4446G), Not Applicable (M34T4481G), Not Applicable (M34T4539G), Not Applicable (H34T3441G), Not Applicable (K34T3978G), Not Applicable (B44T4781G), Not Applicable (F34T2978G), Not Applicable (B44T4745G), Not Applicable (B44T4751G), Not Applicable (D34T2470G), Not Applicable (K24T1184G), Not Applicable (A34T1781G), Not Applicable (A34T1784G), Not Applicable (A34T1785G), Not Applicable (A34T1789G), Not Applicable (A34T1791G), Not Applicable (C34T2407G), Not Applicable (J24T0823G), Not Applicable (D34T2509G), Not Applicable (K34T3886G), Not Applicable (K34T3928G), Not Applicable (K34T3960G), Not Applicable (F24T0276G), Not Applicable (B34T2163G), Not Applicable (B44T4783G), Not Applicable (C34T2235G), Not Applicable (F24T0256G), Not Applicable (J24T0671G), Not Applicable (J24T0700G), Not Applicable (J24T0879G), Not Applicable (J24T0884G), Not Applicable (J34T3686G), Not Applicable (J34T3688G), Not Applicable (J34T3689G), Not Applicable (J34T3693G), Not Applicable (K34T3900G), Not Applicable (K34T3902G), Not Applicable (A44T4704G), Not Applicable (A44T4707G), Not Applicable (K24T1033G), Not Applicable (K24T1039G), Not Applicable (A44T4637G), Not Applicable (A44T4639G), Not Applicable (B44T4747G), Not Applicable (F24T0203G), Not Applicable (G34T3207G), Not Applicable (B34T2019G), Not Applicable (D34T2473G), Not Applicable (D34T2475G), Not Applicable (D34T2491G), Not Applicable (D34T2493G), Not Applicable (D34T2495G), Not Applicable (D34T2518G), Not Applicable (D34T2527G), Not Applicable (D34T2541G), Not Applicable (D34T2546G), Not Applicable (D34T2570G), Not Applicable (D34T2602G), Not Applicable (D34T2604G), Not Applicable (D34T2605G), Not Applicable (D34T2606G), Not Applicable (M34T4318G), Not Applicable (M24T1600G), Not Applicable (M24T1700G), Not Applicable (D34T2482G), Not Applicable (D34T2516G), Not Applicable (D34T2573G), Not Applicable (F34T2854G), Not Applicable (F34T2858G), Not Applicable (F34T2863G), Not Applicable (F34T2864G), Not Applicable (F34T2865G), Not Applicable (F34T2867G), Not Applicable (G24T0448G), Not Applicable (K24T1231G), Not Applicable (K24T1239G), Not Applicable (M24T1677G), Not Applicable (M24T1687G), Not Applicable (M24T1706G), Not Applicable (M24T1712G), Not Applicable (C34T2351G), Not Applicable (C34T2372G), Not Applicable (J34T3653G), Not Applicable (H34T3486G), Not Applicable (J34T3681G), Not Applicable (E34T2726G), Not Applicable (E34T2727G), Not Applicable (E34T2729G), Not Applicable (E34T2732G), Not Applicable (E34T2737G), Not Applicable (F24T0288G), Not Applicable (F24T0289G), Not Applicable (F24T0290G), Not Applicable (F24T0291G), Not Applicable (M24T1504G), Not Applicable (M24T1511G), Not Applicable (M24T1555G), Not Applicable (M24T1561G), Not Applicable (M34T4390G), Not Applicable (B44T4909G), Not Applicable (G24T0543G), Not Applicable (G24T0545G), Not Applicable (H24T0594G), Not Applicable (H34T3265G), Not Applicable (A34T1803G), Not Applicable (F24T0271G), Not Applicable (F24T0284G), Not Applicable (F24T0285G), Not Applicable (F24T0298G), Not Applicable (F24T0299G), Not Applicable (F24T0300G), Not Applicable (F24T0301G), Not Applicable (F24T0303G), Not Applicable (F24T0316G), Not Applicable (G24T0484G), Not Applicable (G24T0488G), Not Applicable (G24T0490G), Not Applicable (G24T0499G), Not Applicable (G24T0542G), Not Applicable (J24T0692G), Not Applicable (J24T0709G), Not Applicable (J24T0710G), Not Applicable (J24T0711G), Not Applicable (J24T0712G), Not Applicable (J24T0716G), Not Applicable (J24T0717G), Not Applicable (J24T0718G), Not Applicable (J24T0722G), Not Applicable (J24T0830G), Not Applicable (K24T1004G), Not Applicable (K24T1014G), Not Applicable (K24T1080G), Not Applicable (F24T0236G), Not Applicable (G24T0411G), Not Applicable (B44T4904G), Not Applicable (F24T0130G), Not Applicable (F24T0272G), Not Applicable (F24T0273G), Not Applicable (G24T0529G), Not Applicable (G24T0538G), Not Applicable (J24T0630G), Not Applicable (J24T0651G), Not Applicable (J24T0691G), Not Applicable (J24T0721G), Not Applicable (J24T0723G), Not Applicable (K24T1007G), Not Applicable (K24T1116G), Not Applicable (K24T1119G), Not Applicable (K24T1120G), Not Applicable (K24T1122G), Not Applicable (K24T1123G), Not Applicable (L24TE1JG), Not Applicable (H34T3277G), Not Applicable (B34T2029G), Not Applicable (B34T2203G), Not Applicable (C34T2268G), Not Applicable (C34T2269G), Not Applicable (C34T2281G), Not Applicable (C34T2397G), Not Applicable (F24T0074G), Not Applicable (F24T0077G), Not Applicable (F24T0078G), Not Applicable (F24T0079G), Not Applicable (G24T0468G), Not Applicable (M24T1442G), Not Applicable (M24T1513G), Not Applicable (M34T4452G), Not Applicable (M34T4453G), Not Applicable (A34T1870G), Not Applicable (B34T1942G), Not Applicable (B34T2111G