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Terminated

Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in the stereotactic irradiation of intracranial structures.

FDA Recall Z-1231-2010 · Posted 2010-04-05

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIWB
Date Initiated2007-05-30
Date Terminated2010-12-28
Product Quantity18 units

Reason for Recall

There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate.

Firm Action

Elekta, Inc. issued a Field Change Order, Reference Number 0000946 dated March 14, 2008. Consignees were informed of the affected product and instructed on necessary steps to take. For further information, contact Elekta, Inc. at 1-770-300-9725.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution -- AR, AZ, CA, FLA, IL, MI, MN, MO, MS, NJ, OH, OR, PA, UT and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063512LEKSELL GAMMA KNIFE PERFEXIONElekta Instrument AB · 2007-03-05

Official Source

View FDA Recall →

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

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