Elekta SL Series/Precise Digital Accelerator. The product is used with radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
FDA Recall Z-1159-2010 · Posted 2010-03-18
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2005-10-01
Date Terminated2010-03-25
Product Quantity315 units
Reason for Recall
Customer reported larger than expected variations in wedge factory with gantry rotation.
Firm Action
Important Notice A280 "Wedge Matching Procedure" (dated 11/18/05) was sent to all effected customers. The Important Notice described the issue, warnings and cautions and corrective instructions/Maintenance to take to eliminate occurrence. Direct questions to your local Elekta Limited representative.
Root Cause
Device Design
Distribution Pattern
United States, Canada and Mexico.
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.
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