VariSource High Dose Rate Afterloader, Models 200, 200t, and ID series. Manufactured by Varian Medical Systems
FDA device recall Z-0976-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 249
- Distribution
- The medical devices for correction had been distributed to medical facilities nationwide and internationally.
- Date initiated
- 2004-05-04
- Date posted
- 2004-07-20
- Date terminated
- 2005-03-09
- Location
- Charlottesville, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.