—#80701

Product

AXIOM Sireskop SX Model numbers 3111676 and 3111668. The product is intended for use as radiographic and fluoroscopic imaging device.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K951358
Affected lot / code info: 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.

Why it was recalled

During interventional use and applications, the possibility exists for liquids to enter the systems.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2009-01-08
Posted by FDA: 2009-05-06
Terminated: 2009-09-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80701. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.