| | Class 2 Recall AXIOM Sireskop SX |  |
| 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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