Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set, GM11004150)
FDA device recall Z-0282-2012 · posted 2011-11-23 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- The Instructions For Use ( IFU) distributed with product prior to 2004 lacks the correct limit to the sterilization cycles and checks regarding the firm seating of the blocking washer.
- Action taken
- Varian Medical Systems sent a Medical Device Recall (PNL-GM-42697-2) in May 2010 for the blocking washer on the flexible probe, Varian part number GM11002420, a component of the Segmented Cylinder Applicator Set. The letter was to inform users that a flexible probe with an unstable or shifted blocking washer must not be used due to the potential for treatment length error. The blocking washer may move from rough handling or sterilization. Users were told to discard any instances of the obsolete Instructions for Use (IFU) in use and replace it with the IFU (PGM11004150 4 March 24, 2010.pdf). A Receipt Verification Card was included requesting consignees to fill out, fax or e-mail immediately to Varian BrachyTherapy.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 81 parts
- Distribution
- Worldwide Distribution: USA, Germany, Belgium, Canada, Mexico City, Spain, Brazil, Switzerland, Uzbekistan, India
- Date initiated
- 2010-05-20
- Date posted
- 2011-11-23
- Date terminated
- 2011-12-05
- Location
- Charlottesville, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS (K033371) | Varian Medical Systems | 2003-12-24 |