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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85352

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

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Event summary

Timeline bucket
March 30, 2020
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.

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. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument

Z-1826-2020
Recall number
Z-1826-2020
Initiated
March 30, 2020
Classification
Class II
Status
Terminated
Recalling firm
Elekta Inc
Quantity
25 units.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.

Code information

Serial Numbers:SH00106, SH00120, SH00149, SH00160, SH00165, SH00110, SH00143, SH00150, SH00161, SH00166, SH00111, SH00144, SH00157, SH00162, SH00167, SH00112, SH00147, SH00158, SH00163, SH00168, SH00114, SH00148, SH00159, SH00164 and SH00178. UDI 7340048304887.

Distribution pattern

US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.