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U.S. Department of Health and Human Services

Class 2 Device Recall AXIOM Sireskop SX

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 Class 2 Device Recall AXIOM Sireskop SXsee related information
Date Initiated by FirmJanuary 08, 2009
Date PostedMay 06, 2009
Recall Status1 Terminated 3 on September 01, 2009
Recall NumberZ-1253-2009
Recall Event ID 51560
510(K)NumberK951358 
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
ProductAXIOM 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 PA 19355
For Additional Information ContactMichael Van Ryn
610-448-4500
Manufacturer Reason
for Recall		During interventional use and applications, the possibility exists for liquids to enter the systems.
FDA Determined
Cause 2		Equipment maintenance
ActionA 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 Commerce669 units
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAA
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