# FDA recall Z-2697-2017

> **Elekta, Inc.** · Class II · device recall initiated 2017-05-23.

## 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).

## 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.

## Distribution

US Distribution to the states of  : NY and PA.

## Key facts

- **Recall number:** Z-2697-2017
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-23
- **Report date:** 2017-07-19
- **Termination date:** 2017-10-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2697-2017

## Citation

> AI Analytics. FDA recall Z-2697-2017. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2697-2017. Source: US FDA. Licensed CC0.

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