—#155629

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).

FDA product code: IWB — System, Radiation Therapy, Radionuclide
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K160440
Affected lot / code info: Serial Numbers 6018, 6047, 6090, 6094, 6171, 8018

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: US Distribution to the states of : NY and PA.

Timeline

Recall initiated: 2017-05-23
Posted by FDA: 2017-05-31
Terminated: 2017-10-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155629. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.