Z-0328-2012

GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide...

Name: Z-0328-2012 GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide...
Creator: Varian Medical Systems, Inc.
Published: 2008-09-30
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2008-09-30 / Terminated / root cause: manufacturing process

FDA source

Varian Medical Systems, Inc. began a recall of GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by... on 2008-09-30. The reason FDA records is "Plastic needle tip could possibly crack or separate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0328-2012
Status: Terminated
Initiated: 2008-09-30
Posted: 2011-12-01
Terminated: 2011-12-07
Recalling firm: Varian Medical Systems, Inc.
Product: GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany. The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles, each needle is supplied with a mandrin.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: Plastic needle tip could possibly crack or separate.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Varian Medical Systems sent a "CUSTOMER TECHNICAL BULLETIN" letter dated September 30, 2008 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed users to inspect needle tips before and after every clinical application to prevent needle tip separation or cracking.
Quantity in commerce: 1716 parts
Distribution: Worldwide Distribution - USA (nationwide) including the states of Arizonia, California, Florida, Illinois, Indiana, Michigan, North Carolina, and Vermont, and the countries of Argentina, Austria, Belgium, Canada, Estonia, France, Germany, India, Norway, Pakistan, Russia, Slovenia, So. Africia, Spain, Switzerland, United Kingdom, and Ukraine.
Product codes and lots: Part number GM11007580

Product code JAQ

K983436Class IIGammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA / cleared 1998-10-29

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)