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Terminated

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Recall Z-1072-2013 · Posted 2013-04-09

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeJAI
Date Initiated2013-03-14
Date Terminated2015-03-17
Product Quantity443

Reason for Recall

The Column rotation can accidentally be moved to a different position which in the locked position.

Firm Action

Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated March 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Elekta office for questions about this notice.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983678ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLEElekta Instruments, Inc. · 1999-01-15

Official Source

View FDA Recall →

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

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