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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72166

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

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Event summary

Timeline bucket
August 27, 2015
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¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Z-0115-2016
Recall number
Z-0115-2016
Initiated
August 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Viewray Incorporated
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.

Code information

Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105

Distribution pattern

US Distribution to the states of : CA, MO and WI., and Internationally to Korea.