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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90505

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

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Event summary

Timeline bucket
June 10, 2022
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

RayStation 11B

Z-1299-2022
Recall number
Z-1299-2022
Initiated
June 10, 2022
Classification
Class II
Status
Terminated
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
26

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

Reason for recall

This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.

Code information

UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68

Distribution pattern

US Nationwide distribution in the states of NJ and TX.