Z-2222-2010

SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imager), Fluoroscopic...

Name: Z-2222-2010 SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imager), Fluoroscopic...
Creator: Siemens Medical Solutions USA, Inc
Published: 2010-07-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2010-07-13 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imager), Fluoroscopic x-ray diagnostic system on 2010-07-13. The reason FDA records is "Fluid may enter the multi-functional handle (Opti Grip) when using the Axiom Luminos TF or Sireskop SD system, causing unintended reaction or movement, increased radiation or useless images". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2222-2010
Status: Terminated
Initiated: 2010-07-13
Posted: 2010-08-13
Terminated: 2012-09-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imager), Fluoroscopic x-ray diagnostic system.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Fluid may enter the multi-functional handle (Opti Grip) when using the Axiom Luminos TF or Sireskop SD system, causing unintended reaction or movement, increased radiation or useless images.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Healthcare Sector sent an "Urgent Field Safety Notice" to consignees describing the issue and informing them to take specific precautions when performing interventional procedures to avoid fluids penetrating the system. The multi-functional handle (Opti Grip) will be replaced through implementation of Update Instructions AX030/10/S. The modified version of the handle resists fluids from entering the handle and prevents malfunction.
Quantity in commerce: 1296
Distribution: Nationwide distribution: all 50 US states and PR.
Product codes and lots: Model numbers 3111668, 3111676, 8890407, 8890415, 10093902. Serial numbers 35059, 35069, 24026, 24030, 41003, 1977, 24020, 34043, 35054, 25014, 1758, 34164, 51041, 34158, 1750, 36038, 36012, 34206, 71135, 24013, 35022, 33036, 36075, 36116, 51059, 1568, 34022, 34042, 36096, 34079, 21037, 34179, 34005, 34188, 34160, 22002, 24031, 1821, 31030, 1471, 31061, 34032, 1830, 1494, 1803, 36010, 41020, 25008, 71011, 31008, 31016, 34161, 36045, 1782, 1906, 1975, 1781, 71069, 71087, 1484, 1452, 1458, 1459, 21029, 1264, 1712, 51012, 21103, 1268, 34070, 34073, 34111, 34210, 36063, 71133, 1988, 1806, 1468, 31029, 31031, 31032, 35052, 1567, 36047, 36059, 1224, 51040, 51055, 2023, 21115, 34181, 36015, 51020, 1502, 1564, 26028, 36117, 1979, 1998, 21010, 34182, 34196, 34211, 35053, 71057, 1963, 71081, 24048, 34015, 36022, 1748, 21007, 1262, 1204, 1218, 1757, 26033, 1728, 21031, 2013, 34093, 33045, 35097, 41006, 1802, 1215, 1216, 34216, 35023, 1760, 21052, 35075, 35068, 71060, 1784, 71048, 1940, 1476, 1726, 1238, 33051, 2032, 26014, 36064, 1255, 21109, 24006, 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26031, 1910, 1911, 1913, 34134, 21086, 51023, 21144, 1981, 34051, 34183, 2022, 1550, 34052, 51010, 71136, 1242, 34193, 51043, 71110, 34077, 1104, 31009, 1570, 1269, 33027, 34025, 35027, 35087, 23006, 71103, 21041, 1267, 24011, 2015, 2017, 1920, 24047, 1945, 34138, 34012, 35015, 35020, 71024, 1246, 71003, 1543, 24002, 1509, 35021, 34177, 71004, 21061, 32028, 1481, 51047, 36080, 1222, 36046, 1524, 36093, 71088, 71140, 34130, 34145, 24005, 71033, 35102, 71055, 33081, 25002, 21018, 31006, 34129, 34198, 35013, 36011, 36097, 31035, 1249, 51015, 21117, 24027, 31063, 1508, 1775, 71177, 1499, 21042, 34006, 71002, 1569, 71115, 21083, 31043, 21009, 1989, 1252, 1759, 1764, 1555, 32007, 34146, 33052, 34085, 34086, 71051, 71090, 1544, 51026, 31042, 1256, 1480, 1260, 1774, 36071, 36079, 34084, 25024, 1765, 1796, 21045, 36031, 34141, 1794, 1787, 36036, 31046, 31047, 1225, 71101, 36025, 1545, 71083, 41009, 21154, 34217, 35008, 71005, 36101, 1719, 1720, 34172, 34173, 41024, 71078, 71079, 71067, 34106, 71009, 71165, 33023, 1477, 34100, 51024, 36008, 71080, 1109, 34122, 33067, 35028, 35029, 71114, 71152, 35025, 35062, 34116, 1776, 1951, 33074, 71141, 71154, 1485, 1486, 1487, 1488, 33015, 34126, 1513, 24016, 1206, 1928, 33003, 21127, 1500, 1483, 1761, 1931, 1511, 31021, 24035, 51068, 71097, 1930, 71015, 33010, 1451, 1100, 1245, 2029, 1722, 1791, 1525, 1902, 1993, 1994, 1792, 1999, 1701, 41022, 71096, 1559, 71025, 51048, 36029, 1745, 33076, 1925, 35073, 1575, 34016, 1723, 34135, 41027, 41028, 71117, 71119, 71120, 71121, 1718, 33017, 24039, 71028, 22011, 23001, 36073, 34195, 34123, 21090, 34021, 1751, 32040, 1540, 2018, 1933, 1232, 71010, 71112, 36098, 71106, 1904, 51031, 51035, 51039, 1729, 34120, 1254, 1454, 1472, 32037, 33077, 34207, 71026, 35078, 71149, 34148, 71016, 1992, 34209, 71014, 21028, 71082, 71066, 1995, 35045, 36081, 36019, 36040, 24025, 71142, 71074, 1265, 21116, 1985, 71019, 32024, 33078, 1473, 1581, 51054, 1831, 35003, 36094, 33058, 34049, 25007, 36060, 24043, 25005, 1239, 1261, 1450, 1456, 1457, 1505, 1506, 31076, 31041, 31045, 34107, 1530, 34091, 1976, 1756, 1731, 36041, 23017, 21051, 26027, 1514, 71007, 36017, 24038, 34174, 1772, 1817, 51013, 71125, 32021, 34075, 71040, 1105, 71160, 35105, 1539, 33002, 51056, 1549, 21119, 35106, 1716, 34124, 1490, 71038, 23002, 23004, 33080, 1984, 2003, 71111, 41017, 32020, 71126, 71145, 1201, 1929, 34121, 36083, 1832, 36057, 34162, 41019, 21025, 71053, 1205, 1207, 41002, 1553, 1747, 2002, 71162, 24010, 24008, 1496, 33056, 71030, 34176, 1952, 1953, 2004, 1495, 1727, 1959, 1961, 1536, 35026, 35044, 21016, 36105, 34089, 32009, 41013, 41023, 71022, 1211, 1533, 34087, 71129, 2024, 1518, 1721, 21082, 71104, 36023, 1469, 26010, 36069, 51030, 1528, 1563, 1705, 1732, 1749, 2000, 21077, 21081, 24034, 34067, 34081, 34103, 71150, 34004, 51044, 1755, 34018, 24049, 1515, 71061, 23020, 21068, 34007, 34008, 35009, 36039, 71001, 26008, 34187, 71008, 34213, 34048, 33072, 1814, 71174, 1967, 1986, 1702, 36026, 51069, 32034, 1819, 1923, 1924, 33028, 36030, 35076, 35092, 34154, 34156, 34128,1818, 51017, 1489, 21143, 22003, 35090, 71043, 36042, 32025, 51052, 51064, 41010, 71091, 71139, 26030, 1941, 1733, 33064, 34034, 25031, 34098, 34147, 21132, 32039, 1955, 35100, 36005, 71018, 34139, 34205, 25020, 25022, 36111, 51011, 34150, 34068, 51063, 1532, 1730, 1907, 1230, 34102, 35051, 33037, 1767, 34028, 34171, 34017, 71181, 71075, 71147, 1212, 41014, 34159, 1577, 41029, 34014, 32027, 51050, 1956, 1217, 1969, 1980, 36061, 26025, 24009, 1517, 1936, 1937, 1482, 35110, 35114, 1962, 31028, 35056, 1828, 22009, 34035, 21055, 71123, 34001, 34002, 71124, 2026, 34118, 34031, 34046, 36043, 1461, 71100, 36067, 36068, 36070, 36086, 1520, 1946, 1909, 33054, 71163, 21011, 25015, 51058, 34197, 26005, 1241, 71063, 51009, 35049, 71032, 33033, 1948, 1453, 1740, 26026, 26029, 33005, 1102, 35018, 1826, 1734, 35074, 1724, 71059, 71179, 31070, 35039, 33060, 2030, 36090, 51037, 36099, 25006, 1987, 35032, 34186, 31044, 31072, 22001, 1547, 34090, 21015, 21038, 32032, 21022, 34152, 32005, 35050, 71161, 71158, 34094, 1491, 1753, 1209, 26001, 41012, 2025, 36092, 1746, 71159, 51061, 71045, 1548, 31038, 34095, 33046, 31078, 21070, 41026, 36110, 51004, 24015, 1926, 34163, 1562, 35030, 35031, 71102, 34178, 71180, 34110, 36077, 36020, 36018, 71020, 35064, 35081, 36053, 21139, 1464, 25053, 36066, 41007, 41018, 1717, 31025, 33022, 51007, 51008, 51065, 33006, 33007, 1812, 23013, 35055, 41008, 36034, 31027, 2020, 1743, 1770, 34208, 36028, 31011, 21089, 21114, 36027, 33063, 33032, 71157, 34020, 35095, 35101, 35085, 1807, 21074, 51022, 33008, 36048, 71166, 36055, 51036, 1556, 34011, 34167, 71006, 1983, 36050, 1460, 33049, 51070, 36009, 71146, 25019, 33029, 1738, 31074, 36054, 51057, 33057, 35091, 35093, 51003, 1804, 1978, 25001, 71148, 71156, 35080, 36076, 1229, 1571, 1833, 51046, 1497, 1541, 71116, 1942, 1944, 51002, 35014, 51001, 1522, 31066, 33001, 34045, 35016, 36065, 51019, 51016, 1972, 1551, 33038, 33055, 35040, 33004, 34054, 34143, 35038, 21050, 21094, 21153, 25026, 35111, 71064, 71128, 71131, 1947, 1711, 1707, 51005, 1535, 1715, 71108, 71068, 1479, 35107, 35006, 35067, 1527, 41005, 31033, 33086, 51060, 35046, 1725, 31060, 36089, 1233, 26024, 71137, 1704, 1736, 1834, 36091, 71027, 24032, 34058, 71144, 1798, 1823, 1935, 25017, 32033, 2009, 24040, 71086, 26016, 32017, 36049, 1957, 71089, 71151, 71070, 1560, 34212, 35086, 21121, 34065, 71109, 71130, 34201, 31024, 36052, 1965, 35072, 2019, 1982, 35063, 32006, 1990, 1538, 71122, 36001, 1498, 1503, 1507, 1797, 1901, 1219, 34076, 1546, 23021, 24042, 34055, 34061, 21145, 36058, 71035, 36056, 34127, 1827, 25029, 1703, 1790, 71113, 36035, 34157, 34114, 32038, 21112, 31073, 32030, 34078, 34166, 21035, 33011, 34192, 1829, 1101, 34003, 36044, 71021, 34019, 34215, 1572, 1777, 1210, 1576, 1912, 1939, 2027, 21120, 21155, 1708, 26006, 1966, 34185, 34190, 1106, 24021, 2021, 33043, 1501, 1542, 26017, 21023, 21098, 21133, 21157, 34112, 34115, 34117, 34136, 35034, 35096, 35112, 35113, 36013, 36102, 71029, 71058, 71072, 71084, 71138, 71164, 71168, 71169, 71172, 71178, 1706, 1762, 1771, 1773, 1789, 1800, 1949, 2028, 1927, 1824, 1974, 33012, 33042, 33021, 1778, 23014, 2008, 34200, 1964, 1997, 21053, 21072, 33061, 34219, 34220, 1950, 1958, 71034, 1710, 1780, 1752, 1465, 71039, 24012, 1251, 1915, 1903, 1917, 33016, 35071, 36003, 36108, 1266, 1512, 26022, 51021, 1709, 1779, 1741, 1552, 24007, 26012, 41011, 36033, 21071, 71127, 24045, 34033, 34097, 34074, 35007, 34108, 35060, 34133, 36007, 34040, 35005, 35011, 21150, 33069, 34027, 34214, 34037, 34184, 1713, 1714, 1954, 21044, 1537, 33082, 35041, 36115, 51018, 71046, 1510, 21102, 1463, 35115, 36032, 31080, 32011, 1960.

Product code MQB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)