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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82662

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

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Event summary

Timeline bucket
June 27, 2018
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Elekta Instrument AB

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.

How coverage and grouping work

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 GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

Z-1412-2019
Recall number
Z-1412-2019
Initiated
June 27, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Elekta Instrument AB
Quantity
52 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.

Code information

Software Version 11.1

Distribution pattern

Worldwide Distribution - US Nationwide distribution to GA, MD, NJ, PA, PR, WA. International distribution to Australia, Belgium, France, Germany, Hong Kong, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Romania, Russian Federation, Spain, Turkey, United Kingdom.