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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65996

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

Open FDA event record

Event summary

Timeline bucket
July 02, 2013
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

Monaco RTP System Radiation treatment planning

Z-2276-2013
Recall number
Z-2276-2013
Initiated
July 02, 2013
Classification
Class II
Status
Terminated
Recalling firm
Elekta, Inc.
Quantity
45

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.

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

Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.

Code information

Versions 3.10.00 and later

Distribution pattern

Nationwide Distribution including AK, CA, CO, CT, FL, IL, IN, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, WA and Puerto Rico.