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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77291

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 23, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Elekta, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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).

Z-2697-2017
Recall number
Z-2697-2017
Initiated
May 23, 2017
Classification
Class II
Status
Terminated
Recalling firm
Elekta, Inc.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

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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.

Code information

Serial Numbers 6018, 6047, 6090, 6094, 6171, 8018

Distribution pattern

US Distribution to the states of : NY and PA.