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U.S. Department of Health and Human Services

Class 2 Device Recall Varian Medical System TrueBeam

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  Class 2 Device Recall Varian Medical System TrueBeam see related information
Date Initiated by Firm April 05, 2011
Date Posted May 10, 2011
Recall Status1 Terminated 3 on June 19, 2012
Recall Number Z-2181-2011
Recall Event ID 58590
510(K)Number K092871  
Product Classification stereotactic radiosurgery and radiotherapy system - Product Code IYE
Product Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19;
Code Information Model number H19; Code numbers: H191011, H191019, H191027, H191033, H191012, H191021, H191028, H191037, H191013, H191023, H191030, H191043, H191016, H191025, H191031, H191045, H191018, H191026, H191032, H191047.  Affected NDA Serial numbers: P7-03112, P7-03174, P7-03221.
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Michael Pignataro
650-424-6471
Manufacturer Reason
for Recall		 Position sensor failure mode may result in an inaccurate position calculation. 1. The video returned by one of the two cameras inside the Spectra is all white or all black, and the Spectra stops tracking. Or 2. Certain video intensities are not available on one of the two cameras. The image has abnormally abrupt transitions from dark to light portions, without the normal shades of gray.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Varian Urgent Medical Device Correction, Urgent Field Safety Notice letters were sent to all affected facilities by certified mail on April 5, 2011.
Quantity in Commerce 20
Distribution Nationwide distribution.
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 MEDICAL SYSTEMS, INC.
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