Varian Medical Systems, Inc. GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 113 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 113 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.
Brand
Varian Medical Systems, Inc.
Lot Codes / Batch Numbers
Part number GM11007560
Products Sold
Part number GM11007560
Varian Medical Systems, Inc. is recalling GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 113 mm. Remote controlled radionuclide due to Plastic needle tip could possibly crack or separate.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Plastic needle tip could possibly crack or separate.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026