Precise Treatment Table The Precise Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.
FDA Recall Z-1030-2011 · Posted 2011-02-03
Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeJAI
Date Initiated2008-03-10
Date Terminated2012-08-09
Product Quantity597 units
Reason for Recall
Possible error in the table longitudinal position.
Firm Action
Elekta sent an updated IMPORTANT NOTICE letter dated December 24, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Elekta recommended that all users, and Eleckta field service engineers do regular QA checks to compare the movement of the treatment table in a given axis with the digital readout.
Elekta Service representatives would attach the screws with Loctite and calibrate the axis on these sites.
For questions regarding this recall call 770-670-2548.
Root Cause
Other
Distribution Pattern
Nationwide Distribution and Puerto Rico
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.