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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71318

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

Open FDA event record

Event summary

Timeline bucket
May 21, 2015
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

Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.

Z-1712-2015
Recall number
Z-1712-2015
Initiated
May 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
Elekta, Inc.
Quantity
351

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.

Code information

MUJ/892.5050, Software Builds - 3.3, 4.0, 4.1, 4.3

Distribution pattern

AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NC, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, WI, Argentina, Australia, Bangladesh, Belarus, Botswana, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, Guatemala, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kosovo, Libya, Malaysia, Mexico, Morocco, Namibia, Nepal, New Zealand, Oman, Pakistan, Peru, Philippines, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Suriname, Taiwan, Thailand, Tobago, Ukraine, Venezuela, Vietnam, Zambia