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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89212

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

Open FDA event record

Event summary

Timeline bucket
November 24, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Reflexion Medical, 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

RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"

Z-0470-2022
Recall number
Z-0470-2022
Initiated
November 24, 2021
Classification
Class II
Status
Terminated
Recalling firm
Reflexion Medical, Inc.
Quantity
3 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).

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

Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).

Code information

Model: RXM1000 Serial Numbers/UDI Codes: X11001 / (01)00860003983805(11)210125(21)X11001 X11002 / (01)00860003983805(11)210324(21)X11002 X11003 / (01)00860003983805(11)210524(21)X11003

Distribution pattern

U.S. Nationwide distribution in the states of CA and TX