| Class 2 Device Recall XiO Radiation Treatment Planning System | |
Date Initiated by Firm | May 13, 2009 |
Date Posted | June 15, 2011 |
Recall Status1 |
Terminated 3 on April 09, 2014 |
Recall Number | Z-2568-2011 |
Recall Event ID |
58215 |
510(K)Number | K092132 |
Product Classification |
System planning radiation therapy treatment - Product Code muj
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Product | XiO Radiation Treatment Planning System, XiO Release 4.3.0 through 4.50.00.
Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. |
Code Information |
XiO Release 4.3.0 through 4.50.00 |
Recalling Firm/ Manufacturer |
Computerized Medical Systems Inc 13723 Riverport Drive Suite 100 Maryland Heights MO 63043
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For Additional Information Contact | Christopher Ivicevich 314-993-0003 |
Manufacturer Reason for Recall | In XiO, when the beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. This can occur when dose is calculated, beams are renumbered, and the dose is re-summed only. |
FDA Determined Cause 2 | Software design |
Action | Computerized Medical Systems, Inc. sent an CUSTOMER ADVISORY letter dated May 2009, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer.
Computerized Medical Systems, Inc have created "patches" to resolve the problem.
A User Notice was sent in March 2011, to all users still using the affected software notifying them of the updated software available to correct the problem. This letter was sent by US Mail but no return receipt was included.
For further questions, please call (408) 380-8023. |
Quantity in Commerce | 1116 |
Distribution | Worldwide Distribution -- (USA) nationwide Distribution, including Puerto Rico, and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia, Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Zealand, Nicaragua, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe. |
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 = muj
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