Z-1253-2009

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

Name: Z-1253-2009 AXIOM Sireskop SX Model numbers 3111676 and 3111668. The product is intended for use as radiographic and...
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-01-08
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-01-08 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Sireskop SX Model numbers 3111676 and 3111668. The product is intended for use as radiographic and fluoroscopic imaging device on 2009-01-08. The reason FDA records is "During interventional use and applications, the possibility exists for liquids to enter the systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1253-2009
Status: Terminated
Initiated: 2009-01-08
Posted: 2009-05-06
Terminated: 2009-09-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Sireskop SX Model numbers 3111676 and 3111668. The product is intended for use as radiographic and fluoroscopic imaging device.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: During interventional use and applications, the possibility exists for liquids to enter the systems.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
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.
Product codes and lots: 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.

Product code JAA

K951358Class IISireskop SxSiemens Medical Solutions USA, Inc. / cleared 1995-05-15

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)