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U.S. Department of Health and Human Services

Class 2 Device Recall Leksell Gamma Knife Icon

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  Class 2 Device Recall Leksell Gamma Knife Icon see related information
Date Initiated by Firm May 23, 2017
Date Posted May 31, 2017
Recall Status1 Terminated 3 on October 18, 2017
Recall Number Z-2697-2017
Recall Event ID 77291
510(K)Number K160440  
Product Classification System, radiation therapy, radionuclide - Product Code IWB
Product Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g., metastatic tumors, recurrent glioblastomas, trigeminal neuralgia, medically refractory essential tremor, orbital tumors, ocular tumors, optic nerve tumors, benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas), skull base tumors, head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland), and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal
tumors, arteriovenous malformations, cavernous malformations, skull base tumors).
Code Information Serial Numbers 6018, 6047, 6090, 6094, 6171, 8018
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Jo Kerrigan
770-670-2422
Manufacturer Reason
for Recall		 If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing maintenance on the X-ray generator.
FDA Determined
Cause 2		 Other
Action Elekta sent an Urgent Important Field Safety Notice dated June 2017, to all affected customers. This notice informs users of the specific product and version numbers affected by the issue. The affected devices are spare part Gantry Module (item number 1515698). Customers are also instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative. For further questions, please call (770) 670-2422.
Quantity in Commerce 2
Distribution US Distribution to the states of : NY and PA.
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 = Elekta Instrument AB
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