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Terminated

Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

FDA Recall Z-1232-2010 · Posted 2010-04-05

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIWB
Date Initiated2009-11-06
Date Terminated2010-12-14
Product Quantity32 units

Reason for Recall

There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position.

Firm Action

Elekta, Inc. issued a Field Change Order 200 091 titled "Update Frame Adapter with New Frame Fixation Axle" dated November 6, 2009. Consignees were given instructions to prevent further issues related to the affected device. For further information, contact Elekta, Inc. at 1-770-300-9725.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution -- AZ, CA, FL, IL, KY, MI, MN, MS, MO, NY, NC, OH, OR, PA, SC, TX, 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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