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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87865

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

Open FDA event record

Event summary

Timeline bucket
May 04, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Viewray, 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

ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.

Z-1836-2021
Recall number
Z-1836-2021
Initiated
May 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Viewray, Inc.
Quantity
8 versions

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software anomalies

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.

Code information

French version of the TDS software affected serial numbers: 214, 215, 226 and 240 German or Italian versions of the TDS software affected serial numbers: 203, 232, 108 and 244

Distribution pattern

International distribution only to the countries of France, Germany, Italy, and Switzerland.