Reported Jul 19, 2017 · Terminated
Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from…
Elekta, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta, Inc. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- 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).
- Lot codes and dates
Serial Numbers 601860476090609461718018
- Amount recalled
- 2
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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