| Class 2 Device Recall Acuity with Conebeam Computed Tomography | |
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
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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
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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 |
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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 = KPQ
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