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 Class 2 Recall
AXIOM Sireskop SX
see related information
Date Posted May 06, 2009
Recall Number Z-1253-2009
Product AXIOM Sireskop SX Model numbers 3111676 and 3111668. The product is intended for use as radiographic and fluoroscopic imaging device.
Code Information Serial numbers: 34180, 35073, 35108, 36095, 21055, 21070, 21071, 21113, 23020, 34027, 24018, 25031, 36054, 21084, 31045, 31076, 21157, 31080, 32006, 32011, 34041. 34064, 34155, 34161, 34197, 26001, 26014, 36045, 21072, 21053, 31008, 31016, 31041, 31042, 31073, 31060, 32027, 32030, 32037, 33010, 33046, 34014, 34022, 24006, 34065, 34078, 34100, 24023, 34163, 34166, 35030, 35031, 35110, 35114, 36001, 36042, 26024, 36067, 36068, 36070, 36089, 36118, 31024, 31030, 21098, 21121, 21112, 21144, 32022, 33025, 33037, 33052, 34001, 34002, 34042, 34150, 25020, 25022, 36096, 36111, 21090, 32009, 34183, 36002, 31014, 32414, 21031, 24005, 34130, 34145, 35059, 35069, 31048, 31066, 21154, 22002, 32023, 33001, 33008, 23006, 33021, 33022, 33045, 33070, 33080, 34006, 34018, 34043, 34084, 34098, 24025, 24031, 34147, 34186, 34191, 34216, 35023, 35025, 35032, 35048, 35062, 35067, 25015, 35097, 35101, 26005, 35113, 36048, 36071, 36076, 36079, 21028, 21041, 31025, 31079, 34033, 34068, 34097, 34058, 34074, 35024, 35058, 36066, 26031, 36114, 21042, 31063, 23004, 33036, 23017, 34003, 34090, 24016, 24029, 34206, 35072, 36044, 26030, 36105, 21038, 21015, 21051, 33015, 33032, 34126, 24048, 33029, 34094, 25019, 32018, 32021, 32029, 32034, 33011, 33012, 33028, 33042, 34020, 34075, 34116, 34139, 34159, 34171, 34192, 34205, 35045, 35060, 35064, 35066, 35081, 35087, 35091, 35093, 36009, 36025, 36052, 36081, 21035, 21117, 21153, 33069, 23013, 23014, 24002, 24047, 35006, 25014, 35095, 36021, 36022, 36037, 36112, 21086, 34019, 25006, 32007, 33064, 34034, 34136, 34215, 36013, 26033, 21029, 21109, 21139, 32038, 33081, 34011, 34148, 34154, 34156, 24039, 34209, 35046, 25024, 35094, 36053, 26032, 36107, 21024, 31018, 31017, 22008, 33017, 33082, 34105, 34141, 34176, 36065, 21081, 21077, 32028, 34040, 34054, 34089, 34110, 34217, 35005, 35008, 35011, 35056, 36058, 36069, 36077, 36097, 21061, 24010, 34106, 36033, 31043, 33056, 34037, 34085, 34086, 34108, 34122, 34178, 34184, 35034, 35052, 36073, 36080, 36102, 21044, 21082, 21089, 31032, 31031, 31029, 21083, 21114, 33033, 33038, 33055, 33072, 34044, 34077, 24026, 24030, 34164, 34193, 24043, 25005, 35039, 35111, 36099, 36115, 34017, 34114, 36006, 36093, 31074, 33004, 33006, 33007, 33049, 34070, 34073, 34111, 34210, 35014, 35018, 35026, 25008, 35044, 35063, 35068, 36017, 36026, 36063, 21103, 21016, 21120, 21155, 34007, 34008, 34212, 35009, 36004, 36039, 21068, 35107, 24015, 31047, 34046, 32005, 22011, 33003, 33051, 23021, 24007, 34045, 34055, 34061, 24012, 34138, 24042, 34201, 35028, 35029, 35042, 35050, 35061, 26012, 36046, 21116, 33074, 31021, 24035, 34158, 24040, 35013, 25003, 35049, 36011, 36012, 26007, 36038, 26028, 31009, 23001, 33077, 34071, 31044, 21141, 21145, 31072, 22001, 32016, 33062, 33079, 34038, 34140, 34189, 25001, 35055, 35075, 21052, 21135, 34112, 35112, 35005, 34057, 36100, 22005, 32025, 33016, 33023, 33043, 34048, 34051, 34067, 34081, 34103, 34117, 34133, 24034, 34152, 34213, 35016, 35027, 35057, 36007, 36010, 36018, 36020, 36024, 36029, 36030, 36051, 36060, 36064, 36086, 21022, 31005, 21133, 31061, 31062, 21150, 32019, 32032, 32033, 33014, 33058, 33063, 33086, 34015, 34036, 34049, 34060, 24011, 34076, 34087, 34121, 34123, 34124, 34157, 31462, 34175, 35019, 35089, 35105, 36041, 36055, 21023, 31033, 31027, 34104, 23002, 34107, 34128, 24027, 24041, 25029, 36050, 33024, 34129, 34198, 36083, 36090, 36098, 31071, 33060, 33087, 34021, 24013, 34093,34102, 34120, 34134, 24032, 34172, 34173, 34177, 34188, 35021, 35022, 35051, 35054, 35102, 35106, 35115, 36027, 36032, 36036, 26022, 36101, 21009, 31006, 21018, 21102, 21119, 34219, 34220, 35074, 36092, 21132, 31077, 32039, 34004, 34174, 24038, 35078, 35100, 36005, 36117, 31011, 35085, 24008, 34187, 35015, 35020, 25007, 25023, 25026, 26010, 21045, 34182, 34196, 34211, 21127, 21143, 32003, 32004, 32001, 22003, 33075, 34005, 34028, 34029, 34032, 24009, 34047, 34050, 34066, 34095, 24017, 34115, 34135, 34142, 34146, 34160, 34179, 34181, 34199, 24045, 24049, 25002, 35053, 35065, 35070, 25016, 25017, 35076, 35086, 35090, 35092, 35096, 36015, 26006, 26008, 26016, 26017, 36031, 36034, 36043, 36047, 36059, 36061, 26025, 26026, 26027, 26029, 36087, 21025, 21011, 21115, 31038, 34091, 34207, 36008, 36035, 31028, 36110, 31065, 22009, 33002, 33027, 34025, 34035, 34052, 35003, 35041, 35071, 36003, 36019, 36040, 36094, 36108, 21007, 34062, 36028, 33057, 33076, 34016, 34031, 34046, 34118, 36023, 36056, 36075, 36091, 36116, 31070, 31078, 32017, 32020, 32024, 32040, 33054, 33061, 33078, 34012, 34079, 24020, 24021, 34127, 34143, 34167, 34185, 34190, 34195, 34200, 34208, 35007, 35002, 35038, 35040, 35080, 26009, 36049, 36057, 21010, 21037, 21074, 21050, and 21094.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Michael Van Ryn
610-448-4500
Reason for
Recall
During interventional use and applications, the possibility exists for liquids to enter the systems.
Action A Customer Safety Advisory Notice dated January 8, 2009 was issued to affected customers via Update Instructions AX069/08/S. This letter informed customers of the potential issues and provided instructions to avoid its occurrence. The firm has released an Addendum to the User Manual warning of the potential hazards if liquids penetrate the systems during interventional use and applications. Direct questions about this recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.
Quantity in Commerce 669 units
Distribution Nationwide Distribution.
 
 
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