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Terminated

VariSource High Dose Rate Afterloader, Models 200, 200t, and ID series. Manufactured by Varian Medical Systems

FDA Recall Z-0976-04 · Posted 2004-07-20

Recalling FirmVarian Medical Systems
Recall StatusTerminated
Product CodeJAQ
Date Initiated2004-05-04
Date Terminated2005-03-09
Product Quantity249

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.

Firm 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.

Root Cause

Other

Distribution Pattern

The medical devices for correction had been distributed to medical facilities nationwide and internationally.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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