| Class 2 Device Recall LEKSELL GAMMAPLAN | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = IWB
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