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Class 2 Device Recall STERIS 4085, 5085 & 5085SRT |
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Date Initiated by Firm |
May 14, 2010 |
Date Posted |
June 30, 2010 |
Recall Status1 |
Terminated 3 on February 24, 2012 |
Recall Number |
Z-1941-2010 |
Recall Event ID |
55850 |
510(K)Number |
K090136
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Product Classification |
Surgical Tables - Product Code FQO
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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 OH 44060
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For Additional Information Contact |
440-392-7601
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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
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = FQO and Original Applicant = STERIS Corporation
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