Z-2991-2011

GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm. Remote controlled radionuclide...

Name: Z-2991-2011 GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm. Remote controlled radionuclide...
Creator: Varian Medical Systems, Inc. Oncology Systems
Published: 2011-07-13
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2011-07-13 / Terminated / root cause: design

FDA source

Varian Medical Systems, Inc. Oncology Systems began a recall of GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by... on 2011-07-13. The reason FDA records is "Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2991-2011
Status: Terminated
Initiated: 2011-07-13
Posted: 2011-08-10
Terminated: 2012-06-20
Recalling firm: Varian Medical Systems, Inc.
Product: GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany Product Usage: 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: Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal.
Root cause tag: design
FDA root cause: Device Design
Action: Varian sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated July 13, 2011 to all possibly affected customers. This notification supplements and modifies the previous "Customer Technical Bulletins" originally sent in September 2008. The initial Customer Technical Bulletins informed customers of the possibility that needle tips cans crack and separate. It also reminded users that the product has a limited life and to check needles prior to use as per instructions. Current correction notice letter instruct customers to stop using any plastic needles in inventory with lot numbers C01 to D01 and those with lot numbers starting with H or I. The letter also request that the recalled products be returned to Varian BrachyTherapy for replacement. The letters include information as to where the lot number is located on the device. All appropriate personnel should be notified of the correction notice. Contact information is provided for all geographical areas. USA contact for questions or concerns is 1-800-360-7909.
Quantity in commerce: 601 - all sizes.
Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Austria, Bangladesh, Belgium, Brazil, Canada, Columbia, Cyprus, Czech Republic Denmark, Dominican Republic, Estonia, France, Germany, Greece, Hungary, India, Japan, Kazahastan, Kuwait, Lebanon, Macedonia, Mexico, Moldova, Nepal New Zealand, Norway, Pakistan, Philippines, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Arab Emirates Uruguay, United Kingdom, and Venezuela.
Product codes and lots: Part numbers GM11007560; All lots C01 to D01 and lots H and I

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)