Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy.
FDA Recall Z-1223-2011 · Posted 2011-02-14
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIWB
Date Initiated2005-10-01
Date Terminated2011-03-02
Product Quantity272 units
Reason for Recall
Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped.
Firm Action
Product bulletin Leksell GammaPlan - "Leksell GammaPlan version 5.34" (dated October 2005) was sent to affected Customers as notification of the problem. Field Change Order FCO-DCO-05-0006 (dated November 22, 2005) and Technical Notes Leksell GammaPlan Leksell SurgiPlan Important Notice - "Potential issue using flipped angiographic images" (dated October 2005) was sent to Elekta Service Engineers as notification of the problem. The letters described the issue and the FCO asked the Service Engineers to confirm their receipt of the documentation. The Technical Notes also discussed image visualization requirements and listed recommendations.
Root Cause
Other
Distribution Pattern
Worldwide Distribution
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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