Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
FDA Recall Z-1158-2010 · Posted 2010-03-17
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIWB
Date Initiated2007-07-02
Date Terminated2010-03-25
Product Quantity19
Reason for Recall
Need to modify the closing speed of the shielding doors in the event of an emergency exit
Firm Action
A field action (FCO TN-07-0007) has been performed to modify the shielding door speed on all sites in clinical use. A second Field Change Order 200 069 "Replacement of Door Servo Board" dated 9/16/08 was released.
Root Cause
Other
Distribution Pattern
Worldwide Distribution -- USA, including states of AR, AZ, CA, FL, IL, MI, MN, MS, NJ, OH, OR, PA, UT, VA and countries of France and United Kingdom.
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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