Z-2697-2017Class II

Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures...

Name: Z-2697-2017 Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures...
Creator: Elekta, Inc.
Published: 2017-05-23
License: https://open.fda.gov/license/

Elekta Limited / initiated 2017-05-23 / Terminated

FDA source

Elekta, Inc. began a recall of Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few... on 2017-05-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2697-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-23
Posted: 2017-05-31
Terminated: 2017-10-18
Recalling firm: Elekta Limited
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).
Product code: IWB System, Radiation Therapy, Radionuclide
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 root cause: 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.
Product codes and lots: Serial Numbers 6018, 6047, 6090, 6094, 6171, 8018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2697-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2697-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-07

Product code IWB

K160440Class IILeksell Gamma Knife IconElekta Instrument AB / cleared 2016-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)