• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Siemens see related information
Date Initiated by Firm May 09, 2014
Date Posting Updated June 04, 2014
Recall Status1 Terminated 3 on August 18, 2015
Recall Number Z-1717-2014
Recall Event ID 68312
510(K)Number K081722  
Product Classification System, x-ray, stationary - Product Code KPR
Product Siemens Ysio Systems

Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) ad emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio System is not meant for mammography. The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography *CR) cassettes.
Code Information Model nos. 10281013,10281163, , with serial nos. 30080, 23071, 20045, 31072, 22523, 22776, 22787, 31137, 23021, 20034, 20112, 22775, 22279, 22283, 22280, 22875, 22290, 22576, 22848, 31060, 31136, 31064, 31138, 22326, 23068, 22288, 22114, 22714, 21100, 22960, 23082, 22169, 22601, 21065, 21205, 31017, 31135, 31040, 21086, 22972, 30038, 30047, 23029, 22538, 22658, 21088, 21103, 31120, 21224, 21221, 21223, 21085, 31122, 22597, 22388, 22391, 20115, 22104, 22583, 23097, 22943, 22942, 22585, 22781, 21089, 20093, 20110, 21066, 22404, 22796, 22506, 21031, 30040, 22119, 22599, 22844, 22148, 22880, 21139, 21006, 20155, 30055, 30024, 21114, 21112, 21122, 31069, 21185, 30051, 31078, 30076, 31012, 22429, 22190, 31010, 31011, 22146, 22527, 22520, 22126, 22128, 23138, 31018, 22836, 23083, 23036, 22163, 20089, 20107, 20088, 20106, 21052, 22727, 23098, 22135, 22737, 22872, 22542, 22549, 22551, 22567, 22500, 31075, 22449, 30032, 22350, 31128, 22389, 31004, 22984, 30028, 23020, 31026, 31134, 21213, 22247, 22347, 30078, 22428, 22137, 22917, 22873, 31115, 20167, 31053, 31081, 21174, 22029, 22725, 22724, 31094, 22286, 31019, 22093, 22933, 22920, 22895, 22681, 22676, 22682, 22019, 22020, 21098, 31077, 31119, 30062, 31054, 22080, 31121, 30050, 21057, 22833, 22840, 22955, 31093, 22058, 31046, 22931, 22847, 22852, 22309, 21101, 22612, 21120, 21117, 21116, 21118, 22367, 22600, 22946, 30021, 22655, 22705, 23016, 22699, 22192, 22251, 22899, 31028, 21091, 31071, 22928, 22275, 21092, 22254, 21037, 21077, 21076, 22839, 22117, 22609, 22543, 22821, 30029, 23118, 22838, 22842, 21200, 21209, 21203, 20149, 21163, 22708, 21172, 21171, 21173, 22248, 31067, 31066, 23053, 30066, 30067, 30063, 22789, 22857, 22055, 22050, 22038, 22051, 22056, 22037, 22060, 22242, 22071, 22208, 22073, 22632, 22683, 22666, 22541, 22537, 22364, 23127, 23129, 20094, 22132, 22026, 22027, 22225, 23024, 23022, 30052, 23130, 23132, 22092, 21115, 22456, 22441, 22021, 22730, 22743, 22851, 21113, 22175, 31003, 22584, 20047, 21194, 22786, 31117, 31145, 23018, 23019, 22166, 22170, 22944, 22945, 31079, 23038, 22869, 31103, 31104, 31095, 31047, 20113, 30023, 30027, 30019, 23113, 22431, 22778, 22777, 23047, 21212, 21211, 23035, 22216, 23066, 30037, 22861, 22859, 22824, 22755, 22757, 22693, 22647, 21188, 21186, 22656, 21094, 22390, 21040, 21039, 22076, 22630, 31082, 21108, 22919, 22825, 22054, 22059, 22834, 31143, 22764, 23096, 22517, 22177, 22685, 30033, 30034, 20105, 22998, 23057, 22345, 22849, 22427, 22606, 22525, 22435, 22729, 22370, 22365, 22366, 22246, 22509, 22344, 22700, 30073, 22966, 22748, 20185, 21061, 31037, 23063, 23054, 21095, 22081, 22062, 23117, 22352, 22353, 22354, 21148, 31114, 31133, 22736, 22618, 22828, 22958, 22178, 22458, 22457, 22695, 21189, 21187, 21167, 22702, 22644, 21175, 21140, 21023, 23141, 22462, 21001, 22759, 21004, 21005, 22136, 22211, 21127, 23059, 23079, 22120, 23078, 22202, 22184, 22804, 22392, 22214, 22235, 22234, 22289, 31096, 31142, 22948, 31014, 22316, 22651, 22795, 31043, 31045, 21123, 21013, 22997, 22293, 23123, 23126, 22064, 22592, 22271, 22914, 21160, 22338.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Mail Code: 65-1A
Malvern PA 19355-1418
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall
Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation.
FDA Determined
Cause 2
Use error
Action Siemens sent an Safety Advisory Notice letter dated May 9, 2014, to affected customer. The letter identified the affected product, problem and actions to be taken. For question call +49 (913) 84-9908.
Quantity in Commerce 433
Distribution US Nationwide
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KPR and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
-
-