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Class 2 Device Recall Clinac C series |
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| Date Initiated by Firm |
June 06, 2006 |
| Date Posted |
July 06, 2006 |
| Recall Status1 |
Terminated 3 on December 03, 2007 |
| Recall Number |
Z-1206-06 |
| Recall Event ID |
35728 |
| 510(K)Number |
K862645
|
| Product Classification |
Accelerator, Linear, Medical - Product Code IYE
|
| Product |
Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included. Model numbers 2100, 2100C/D, 21 EX. 2300 C/D, 23 EX, 600C, 600 C/D, 2500 C, Trilogy, 6EX and Silhouette. |
| Code Information |
All lots |
Recalling Firm/
Manufacturer |
Varian Medical Systems Inc
911 Hansen Way
Palo Alto CA 94304
|
Manufacturer Reason
for Recall |
Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.
|
FDA Determined
Cause 2 |
Other |
| Action |
The firm has initiated recall by sending its consignees a product notification letter 06/06/2006, and intends to dispatch service representatives to perform necessary modifications. |
| Quantity in Commerce |
217 units |
| Distribution |
Worldwide |
| 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 = VARIAN ASSOC., INC.
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