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Terminated

Leksell SurgiPlan

FDA Recall Z-1428-2010 · Posted 2010-04-22

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2005-05-23
Date Terminated2010-12-14
Product Quantity57 units

Reason for Recall

Images from a different patient can be imported without a warning for the user.

Firm Action

Phase I - A technical note for LGP and SPS describing the risk for importing wrong image files and including recommendations on how to reduce this risk has been written and distributed to users of both Leksell GammaPlan and Leksell SurgiPlan on May 23, 2005 via FCO DOC 05-0001. Phase 2 - A maintenance release was created of the Scanner Interface (SIF) to correct the problem. This was distributed to Leksell SurgiPlan users on November 30, 2005 via FCO0000153-1. Additional questions are directed to the firm to Product Manager lrobert.aslund AT elekta.com, or After Sales gustaf.piehl AT elekta.com..

Root Cause

Other

Distribution Pattern

Nationwide, Canada and Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K943468LEKSELL SURGIPLANElekta Instruments, Inc. · 1995-01-20

Official Source

View FDA Recall →

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

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