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U.S. Department of Health and Human Services

Class 2 Device Recall Acuity with Conebeam Computed Tomography

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  Class 2 Device Recall Acuity with Conebeam Computed Tomography see related information
Date Initiated by Firm January 03, 2008
Date Posted July 30, 2008
Recall Status1 Terminated 3 on September 30, 2009
Recall Number Z-1460-2008
Recall Event ID 46919
510(K)Number K033339  
Product Classification Radiation therapy simulation system - Product Code KPQ
Product Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.
Code Information Serial Numbers: H770002-H780001, H770012-H780058, H770030-H780034, H770055-H780046, H770068-H780010, H770107-H780050, H770113-H780060, H770119-H780035, H770134-H780026, H770143-H780039, H770159-H780062, H770170-H780056, H770184-H780061, H770212-H780074, H770245-H780086 and H770279-H780105.
Recalling Firm/
Manufacturer		 Varian Medical Systems Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact
650-424-5731
Manufacturer Reason
for Recall		 Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head First Spine. When such images are imported to a treatment planning system, they may appear with either a mirrored or a rotated view.
FDA Determined
Cause 2		 Software design
Action Consignees were notified by an Urgent Medical Device Correction letter issued on 02/05/2008. The letter provided recommended actions for users to follow in order to avoid the software error. The letter informed users that a service pack is being created to correct the issue and that the recalling firm will notify users when it becomes available. For additional information, contact 888-827-4265.
Quantity in Commerce 16 UNITS
Distribution Worldwide Distribution--USA including states of CA, MA and PA, and countries of UK, Chile, Belgium, Canada and Germany.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = KPQ and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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