Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.
FDA Recall Z-1230-2010 · Posted 2010-04-05
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIWB
Date Initiated2008-11-09
Date Terminated2010-12-28
Product Quantity19 units
Reason for Recall
Radiation unit doors could close too fast on emergency exit.
Firm Action
Field Change Order 200 070 "MCU CS SW 8.3" dated September 11, 2008 was released. Consignees were informed of the necessary steps to avoid further issues relating to the affected product.
For further information, contact Elekta, Inc. at 1-770-300-9725.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution -- AR, AZ, CA, FL, IL, MI, MN, MS, MO, NJ, OH, OR, PA, UT and VA.
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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