Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Elekta Synergy The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

FDA Recall Z-3079-2011 · Posted 2011-08-29

Recalling FirmElekta, Inc.
Recall StatusTerminated
Date Initiated2011-05-06
Date Terminated2012-10-02
Product Quantity368

Reason for Recall

A small number of the Modular Reverse Diodes (D1A), a component in the equipment room of the Elekta Linear Accelerator, have ruptured.

Firm Action

ELEKTA sent an IMPORTANT NOTICE (FCO 20000103022), dated May 6, 2011. The notice identified the product, the problem, and the aciton to be taken by the customer. Elekta recommended that service personnel always wear protective safety glasses, when they do work on the modulator assembly with the covers removed. Elekta also recommended that users make sure that the modulator cover is installed when the digital accelerator is in operation. Elekta will release a Field Change Order when a corrective action is identified.

Root Cause

Other

Distribution Pattern

Nationwide and Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051932ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5Elekta, Inc. · 2005-08-12K032996ELEKTA SYNERGY SYSTEMElekta Oncology Systems, Ltd. · 2003-10-23K963624PHILIPS SLI SERIES LINEAR ACCELERATORPhilips Medical Systems, Inc. · 1996-12-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑