Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 1-H63; Product is distributed by Varian Medical Systems Inc., Palo Alto, CA and Manufactured by Varian Medical Systems Haan GmbH, Bergische Strasse 16, D-42781 Haan, Germany. The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device.
FDA Recall Z-0329-2012 · Posted 2011-12-01
Advertisement
Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeJAQ
Date Initiated2011-10-06
Date Terminated2012-10-22
Reason for Recall
The Product Models 1 & 2 have a design flaw problem where the clamping adapter can
obstruct movement of the source cable in the event the bronchial catheter is dislodged
from the connector.
Firm Action
Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION LETTER/FIELD SAFETY NOTICE" letter dated October 6, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Contact the Varian Help Desk at 1-888-827-4265 for questions regarding this notice.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution--USA (nationwide).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement