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Class 2 Device Recall MOSAIQ |
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Date Initiated by Firm |
November 24, 2015 |
Create Date |
December 17, 2015 |
Recall Status1 |
Terminated 3 on September 15, 2021 |
Recall Number |
Z-0447-2016 |
Recall Event ID |
72725 |
510(K)Number |
K141572
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Product Classification |
Accelerator, linear, medical - Product Code IYE
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Product |
MOSAIQ Oncology Information System.
Used to manage workflows for treatment planning and delivery. |
Code Information |
Versions prior to 2.60. |
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 770-670-2422
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Manufacturer Reason for Recall |
First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.
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FDA Determined Cause 2 |
Software design |
Action |
Elekta sent an Urgent Important Field Safety Notice 371-01-MSQ-004 to all affected customers on 11/24/2015. The notice informs users to the issue, the work around and the solution. The customers are instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta Office or Representative, as soon as possible but no longer than 30 days from receipt. |
Quantity in Commerce |
211 |
Distribution |
Nationwide Distribution -- AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, & Puerto Rico. |
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 = IMPAC MEDICAL SYSTEMS, INC.
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