Z-0282-2012

Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set...

Name: Z-0282-2012 Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set...
Creator: Varian Medical Systems, Inc.
Published: 2010-05-20
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2010-05-20 / Terminated / root cause: labeling and UDI

FDA source

Varian Medical Systems, Inc. began a recall of Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set, GM11004150) on 2010-05-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0282-2012
Status: Terminated
Initiated: 2010-05-20
Posted: 2011-11-23
Terminated: 2011-12-05
Recalling firm: Varian Medical Systems, Inc.
Product: Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set, GM11004150)
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 81 parts
Distribution: Worldwide Distribution: USA, Germany, Belgium, Canada, Mexico City, Spain, Brazil, Switzerland, Uzbekistan, India
Product codes and lots: Lot number Y01 to E19

Product code JAQ

K033371Class IIVarian Intracavitary Brachytherapy ApplicatorsVarian Medical Systems / cleared 2003-12-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)