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U.S. Department of Health and Human Services

Class 2 Device Recall STERIS 4085, 5085 & 5085SRT

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 Class 2 Recall
STERIS 4085, 5085 & 5085SRT
see related information
Date Posted June 30, 2010
Recall Status1 Terminated on February 24, 2012
Recall Number Z-1941-2010
Recall Event ID 55850
Premarket Notification
510(K) Number
K090136 
Product Classification Table, Operating-Room, Ac-Powered - Product Code FQO
Product STERIS 4085, 5085 & 5085SRT Surgical Tables
Code Information Model #: 4085, 5085 & 5085SRT Serial Numbers: 0400710041, 0400710042, 0400710043, 0400710044, 0401510077, 0401510080, 0401510081, 0401510082, 0401510086, 0401510087, 0401510088, 0401510089, 0401510090, 0401510092, 0401910133, 0402010001, 0402010002, 0402010003, 0403210095, 0403210096, 0403210096, 0403210097, 0403210098, 0403610046, 0403610047, 0403610048, 0403610049, 0403610050, 0403610053, 0403610054, 0403610055, 0403610057, 0403610061, 0403610062, 0403610063, 0404610061, 0404610062, 0404610063, 0404610063, 0404610064, 0404610064, 0404610065, 0404610065, 0404610070, 0404610070, 0404610071, 0404610071, 0404610072, 0404610072, 0405410037, 0405410038, 0405410039, 0432709078, 0432709079, 0432709079, 0432709080, 0432709081, 0432709082, 0432709083, 0432709083, 0432709084, 0432709084, 0433609001, 0433609001, 0433609002, 0433609002, 0433609005, 0433609005, 0433609062, 0434309100, 0434309101, 0434309103, 0434809001, 0434809003, 0434809004, 0434809005, 0434809006, 0434809007, 0434809007, 0434809008, 0434809008, 0434809012, 0434809013, 0434809014, 0434809014, 0434809015, 0434809015, 0434809016, 0434809016, 0434809017, 0434809017, 0434809018, 0434809018, 0434809019, 0434809019, 0436309084, 0436309085, 0436509122, 0436509123, 0436509124 & 0436509124.
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor, Ohio 44060
Manufacturer Reason
for Recall
STERIS has learned that a limited quantity of manifold assemblies were manufactured by our supplier with incorrect washers and springs in the valves of the manifold. This supplier error has the potential to cause: a) an inability to articulate/move a table section when commanded by the operator; b) two different articulations occurring when a single articulation is commanded, or c) that the table
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action On May 14, 2010 the firm sent FCL letters to their customers notifying them of the problem. They informed their customers that a service representative will contact them to arrange correction of the unit.
Quantity in Commerce 79 units
Distribution Worldwide distribution: USA, Australia, India, Korea & New Zealand
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FQO and Original Applicant = STERIS CORPORATION
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