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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73550

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

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Event summary

Timeline bucket
March 07, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Viewray Incorporated

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

MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated

Z-1309-2016
Recall number
Z-1309-2016
Initiated
March 07, 2016
Classification
Class II
Status
Terminated
Recalling firm
Viewray Incorporated
Quantity
5 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software will

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

When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.

Code information

Model number: 10000 Catalog/Part Number: 10000 Serial Numbers: 100, 101, 102, 104 & 105

Distribution pattern

Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.