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U.S. Department of Health and Human Services

Class 2 Device Recall LEKSELL GAMMAPLAN

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  Class 2 Device Recall LEKSELL GAMMAPLAN see related information
Date Initiated by Firm October 23, 2008
Date Posted April 27, 2010
Recall Status1 Terminated 3 on December 14, 2010
Recall Number Z-1134-2010
Recall Event ID 54631
510(K)Number K973441  
Product Classification Radionuclide radiation therapy system - Product Code IWB
Product Leksell GammaPlan.

Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professional (Neurosurgeons, Radiation Therapists and Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.
Code Information 4113, 4115, 4142, 4148, 4158, 4160, 4176, 4191, 4193, 4195, 4207, 4208, 4300, 4302, 4303, 4306, 4308, 4309, 4313, 4314, 4319, 4326, 4328, 4329, 4332, 4333, 4337, 4339, 4340, 4341, 4342, 4343, 4344, 4346, 4349, 4352, 4353, 4354, 4363, 4366, 4824, 4830,5000, 5003, 5019, 5023, 5026, 5034, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032, 6034, 6035, 6036, 6037, 6047 and 6049.
Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information Contact Thomas Valenitne
770-670-2548
Manufacturer Reason
for Recall		 Although the co-registration looks good during the verification step in the co-registration dialog, the obtain transformation may include an error that depends on the voxel sizes and acquisition parameters of the co-registered image studies.
FDA Determined
Cause 2		 Other
Action Important Notice A325 "Error in ImageMerge" dated November 21, 2008 was sent to affected customers and field service engineer as notification of the problem. The notice advises users not to use ImageMerge except if it is judged that the transformation error has no clinical significance. Information is provided in the release to help the user to make an informed decision on this issue. Field Change Order 200 084, "NTPS 8.3 SP1 for NTPS 8.0, 8.2 and 8.3" released January 28, 2009 was sent to affected customers as notification of the fix to this issue. This notice includes instructions to assist Elekta field service personnel in successfully upgrading the affected systems. Once the upgrade is in place, the issue will be corrected.
Quantity in Commerce 72 units
Distribution Nationwide Distribution -- (AL, AZ, AR, CA, CO, FL, GA, HI, IL,KY, MA, MI, MS, NE, NV, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN TX and UT).
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IWB and Original Applicant = PATTERSON CONSULTING GROUP, INC.
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