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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88771

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

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Event summary

Timeline bucket
September 28, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ELEKTA SOLUTIONS 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

Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.

Z-0115-2022
Recall number
Z-0115-2022
Initiated
September 28, 2021
Classification
Class II
Status
Terminated
Recalling firm
ELEKTA SOLUTIONS AB
Quantity
2 in the U.S.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.

Code information

Elekta Harmony Pro, Serial #441009, UDI (01) 05060191071604; Elekta Infinity, Serial #156645, UDI (01) 05060191071543; and Elekta Versa HD, Serial #156646, #156477, and #156648, UDI (01) 05060191071574

Distribution pattern

Distribution was to ND and NC. There was no military/government distribution.