Recalls / —
—#90064
Product
Leksell SurgiPlan
- FDA product code
- HAW — Neurological Stereotaxic Instrument
- Device class
- Class 2
- Medical specialty
- Neurology
- 510(k) numbers
- K943468
- Affected lot / code info
- US68104248, SG50425261, US68154313, US66320311, 3415G15729, 3416G05185, SW ONLY, 3416G07810, 3416G08464, US19311023, SG5121735, SG44720158, 000000000000010, SG33221023, 000000000000015, SG41020267, US19477688, SG14720637, SG31020878, SG21220437, IE24488098, SG11720734, US6836799, SG20220679, US68064889, US19344670, SG41720337, SG44820136, US6863578, US68247174, SG20220701, 000000000000011, 6458A30012, HP715/80, 000000000000019, 3628G06513, SG5020708, SG31120383, LGP-SG13420315, 000000000000014, 00000000000004, 3711C04231, US68154724, C160, SG33820630, 00000000000002, 000000000000013, 6146A06124, SG41920535, 6513A30173, 0304011939, A4986A, SG20220694, 000000000000016, SG20220699, 6601A30228, US19476876
Why it was recalled
Images from a different patient can be imported without a warning for the user.
Root cause (FDA determination)
Other
Action the firm took
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..
Recalling firm
- Firm
- Elekta, Inc.
- Address
- 4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011
Distribution
- Distribution pattern
- Nationwide, Canada and Mexico.
Timeline
- Recall initiated
- 2005-05-23
- Posted by FDA
- 2010-04-22
- Terminated
- 2010-12-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #90064. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.