Exact FDA event identifier

Event 79582

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

Open FDA event record

Event summary

Timeline bucket: January 26, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: RAYSEARCH LABORATORIES AB

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

Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130

Z-1275-2018

Recall number: Z-1275-2018
Initiated: January 26, 2018
Classification: Class II
Status: Terminated
Recalling firm: RAYSEARCH LABORATORIES AB
Quantity: 2484

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software issue with Center Beam in Field functionality. Issue

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

Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.

Code information

Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19

Distribution pattern

Nationwide