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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85836

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

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Event summary

Timeline bucket
June 10, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
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 Vantage Stereotactic System, UDI/GTIN 7340048304887

Z-2442-2020
Recall number
Z-2442-2020
Initiated
June 10, 2020
Classification
Class II
Status
Terminated
Recalling firm
Elekta Instrument AB
Quantity
51 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.

Code information

Serial numbers: SH00026, SH00049, SH00061, SH00082, SH00092, SH00111, SH00028, SH00050, SH00072, SH00084, SH00094, SH00118, SH00029, SH00052, SH00073, SH00085, SH00095, SH00121, SH00030, SH00054, SH00074, SH00086, SH00097, SH00123, SH00032, SH00055, SH00077, SH00087, SH00099, SH00127, SH00033, SH00057, SH00078, SH00088, SH00100, SH00162, SH00041, SH00058, SH00079, SH00089, SH00102, SH00044, SH00059, SH00080, SH00090, SH00105, SH00045, SH00060, SH00081, SH00091, SH00108

Distribution pattern

MA, IL, NH, NC, UT, OH, FL, MN, TX, NY, LA, AZ, MT, WV, Austria, Croatia, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lithuania, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom