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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84330

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

Open FDA event record

Event summary

Timeline bucket
November 22, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

Monaco Radiation Treatment Planning System (RTP) System

Z-0670-2020
Recall number
Z-0670-2020
Initiated
November 22, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Elekta Inc
Quantity
76 (7 US, 69 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Monaco is using the incorrect energy when optimizing and calculating dose.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Monaco is using the incorrect energy when optimizing and calculating dose.

Code information

Software Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (01)00858164002268(10) 5.51.00

Distribution pattern

IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.