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Terminated

Elekta Synergy Intended to be used for radiation therapy treatment of malignant neoplastic diseases.

FDA Recall Z-1441-2010 · Posted 2010-04-27

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-03-18
Date Terminated2010-12-14
Product Quantity184 units

Reason for Recall

Installation of a touchguard to prevent injury to patients or staff by stopping machine movements in the case of accidental collision.

Firm Action

An Important Notice A319 "Instructions for Use for Elekta Synergy kV Source Touchguard" dated 3/18/08 is in distribution to all affected customers. This letter identified the product and asked customers to file the Notice in the User Notice section of the appropriate User Manual. It also asked them to follow the instructions and the reason for the Notice. Questions should be directed to a local Elekta representative. Field Change Order (FCO) 514 259 "kV Source touchguard for systems with touchguard ready source covers" dated 10/17/08 was sent to all affected customers. FCO 514 260 "kV Source touchguard for systems with the original source covers" dated 10/17/08 was sent to all affected customers.

Root Cause

Finished device change control

Distribution Pattern

Nationwide Distribution -- Including Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032996ELEKTA SYNERGY SYSTEMElekta Oncology Systems, Ltd. · 2003-10-23

Official Source

View FDA Recall →

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

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