| Class 2 Device Recall MOSAIQ |  |
Date Initiated by Firm | June 17, 2016 |
Create Date | June 27, 2016 |
Recall Status1 |
Terminated 3 on August 18, 2020 |
Recall Number | Z-2052-2016 |
Recall Event ID |
74378 |
510(K)Number | K141572 |
Product Classification |
Accelerator, linear, medical - Product Code IYE
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Product | MOSAIQ Oncology Information System |
Code Information |
Versions 2.62 and higher |
Recalling Firm/ Manufacturer |
Elekta, Inc. 400 Perimeter Center Ter NE Ste 50 Atlanta GA 30346-1227
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For Additional Information Contact | Linda Wetsel 404-993-5886 |
Manufacturer Reason for Recall | It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan. |
FDA Determined Cause 2 | Software design |
Action | Elekta sent an Important Field Safety Notice to all customers on June 17, 2016.
The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. A software patch will be issued for Mosaiq version 2.62 in order to the correct the defect. For further questions please call (404) 993-5886. |
Quantity in Commerce | 69 |
Distribution | US Distribution including Puerto Rico and to the states of : AK, AZ, CA, FL, GA, IL, IN, LA, MD, MI, MO, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and to the countries of : Canada, Denmark, Finland, Germany, Israel, Japan, Netherlands, Norway, Sweden, 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
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