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U.S. Department of Health and Human Services

Class 2 Device Recall Clinac 21EXS Sihlouette

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  Class 2 Device Recall Clinac 21EXS Sihlouette see related information
Date Initiated by Firm March 30, 2005
Date Posted September 09, 2005
Recall Status1 Terminated 3 on September 08, 2005
Recall Number Z-1530-05
Recall Event ID 31633
510(K)Number K904364  K913119  
Product Classification Accelerator, Linear, Medical - Product Code IYE
Product Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac);

Distributed by and/or Manufactured by: Varian Medical Systems, Palo Alto, CA 94304.
Code Information Affected Serial Numbers: H140001, H140002, H140003, H140004, H140005, H140006, H140007, H140009, H140022, H140010, H14001, H140012, H140013, H140014, H140015, H140016, H140017, H140018, H140019, H140021, H140023, H140024, H140025.
Recalling Firm/
Manufacturer		 Varian Medical Systems Inc
3100 Hansen Way
M/S E-210
Palo Alto CA 94304
For Additional Information Contact Mark Perkins
650-424-6640
Manufacturer Reason
for Recall		 Emergency Off Switch located on the device may not function correctly resulting in the device remaining powered on after the switch is activated.
FDA Determined
Cause 2		 Device Design
Action On 3/16/05, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.
Quantity in Commerce 24 units
Distribution US distribution is: CA, CT, IL, IN, KY, OH, MI, NC, NJ, NY, SC, TN, TX, VA, & WA, totaling 22 hospitals. Foreign distribution includes: Denmark, Hong Kong, and Japan. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers.
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 = IYE and Original Applicant = VARIAN ASSOC., INC.
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