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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 04, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on March 09, 2005
Recall Number Z-0976-04
Recall Event ID 29005
Product Classification System, Applicator, Radionuclide, Remote-Controlled - Product Code JAQ
Product VariSource High Dose Rate Afterloader, Models 200, 200t, and ID series. Manufactured by Varian Medical Systems
Code Information Config ID/Serial# (Domestic) ACC01220 VS00014 VS00015 VS00016 VS00017 VS00025 VS00028 VS00029 VS00034 VS00036 VS00037 VS00045 VS00047 VS00048 VS00049 VS00050 VS00051 VS00052 VS00053 VS00054 VS00055 VS00058 VS00064 VS00065 VS00066 VS00067 VS00068 VS00070 VS00072 VS00075 VS00076 VS00077 VS00078 VS00082 VS00083 VS00084 VS00085 VS00086 VS00089 VS00095 VS00204 VS00205 VS00207 VS00208 VS00209 VS00210 VS00212 VS00214 VS00215 VS00217 VS00219 VS00220 VS00221 VS00222 VS00223 VS00225 VS00226 VS00227 VS00230 VS00231 VS00232 VS00233 VS00234 VS00236 VS00237 VS00238 VS00243 VS00245 VS00246 VS00251 VS00253 VS00255 VS00256 VS00257 VS00258 VS00261 VS00262 VS00265 VS00266 VS00268 VS00271 VS00276 VS00281 VS00282 VS00283 VS00286 VS00287 VS00288 VS00289 VS00292 VS00296 VS00298 VS00299 VS00300 VS00300-1 VS00302 VS00303 VS00304 VS00305 VS00306 VS00307 VS00309 VS00310 VS00311 VS00314 VS00315 VS00316 VS00317 VS00318 VS00319 VS00320 VS00321 VS00322 VS00323 VS00325 VS00326 VS00327 VS00328 VS00329 VS00330 VS00331 VS00332 VS00333 VS00334 VS00336 VS00337 VS00340 VS00341 VS00342 VS00343 VS00344 VS00345 VS00347 VS00348 VS00349 VS00350 VS00352 VS00355 VS3184177491000 VS3184191051000 VS3184610861000 VSBASSETT VSSTBERNADINESS VSSTOCK 
Recalling Firm/
Manufacturer		 Varian Medical Systems
700 Harris St
Suite 109
Charlottesville VA 22903-4584
For Additional Information Contact Mark Kattmann
434-977-8495 Ext. 232
Manufacturer Reason
for Recall		 Manufacturer of brachytherapy instrument issued a Customer Technical Bulletin to clarify instructions for use of the radiation treatment medical device by healthcare practitioners.
FDA Determined
Cause 2		 Other
Action The recalling firm notified end users by letter and Customer Technical Bulletin on 5/4/04. The notification informed users not to use the Emergency retract hand wheel to recover a dummy wire and to reinforce the instructions already in the procedures that in the event of an Active wire becoming stuck out, the user should not turn the emergency retract hand wheel in excess of 20 times, or until the wire has parked and the radiation alarm has silenced. Advised of proper procedures for retracting the active wire and a warning concerning excessive turning of the emergency retract handwheel. The notification also states that customer user manuals and handwheel labeling will be updated at next service visit.
Quantity in Commerce 249
Distribution The medical devices for correction had been distributed to medical facilities nationwide and internationally.
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.
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