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Terminated

Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures

FDA Recall Z-1236-2010 · Posted 2010-04-13

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIWB
Date Initiated2007-10-01
Date Terminated2010-12-28
Product Quantity5 units

Reason for Recall

After updating the LGK actuator in spare part 810361, the old sleigh became obsolete due to causing insufficient locking of the helmet in combination with the new actuator.

Firm Action

Field Change Order 0000203 "Replacement of obsolete actuator sleigh on Helmet Changer", was sent to all customers that were affected. Direct questions to Elekta, Inc. by calling 1-770-670-2548.

Root Cause

Other

Distribution Pattern

United States (CA, TN, TX and WA) and Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984328LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001Elekta Instrument AB · 1999-05-21

Official Source

View FDA Recall →

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

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