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Class 2 Device Recall VARiS Version 6.6 |
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Date Initiated by Firm |
September 20, 2005 |
Date Posted |
August 05, 2006 |
Recall Status1 |
Terminated 3 on November 21, 2006 |
Recall Number |
Z-1375-06 |
Recall Event ID |
35886 |
510(K)Number |
K050479
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Product Classification |
Accelerator, Linear, Medical - Product Code IYE
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Product |
Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators |
Code Information |
H462074, H462000, H462003, H462004, H462005, H462006, H462011, H462012, H462013, H462014, H462015, H462016, H462017, H462018, H462019, H462020, H462021, H462022, H462023, H462024, H462025, H462026, H462027, H462028, H462029, H462031, H462040, H462045, H462047, H462048, H462049, H462050, H462051, H462052, H462054, H462055, H462057, H462059, H462060, H462061, H462064, H462065, H462066, H462067, H462068, H462072, H462073, H462075, H462076, H462077, H462079, H462082, H462083, H462084, H462085, H462086, H462087 |
Recalling Firm/ Manufacturer |
Varian Medical Systems Oncology Systems 911 Hansen Way Palo Alto CA 94304-1028
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Manufacturer Reason for Recall |
A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators .
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FDA Determined Cause 2 |
Software design |
Action |
On 09/20/2005, Varian Medical Systems issued a notification letter via certified mail and FedEx. These letters were issued with instructions on what to do regarding the corrections. Varian Medical Systems intends to release new, updated software. |
Quantity in Commerce |
58 units |
Distribution |
The product was distributed to 34 consignees, located in AZ, CA, MA, MI, NC, PA in the USA, and in Australia, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Lithuania, Spain, Sweden, and the United Kingdom |
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 = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS
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