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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64986

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

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Event summary

Timeline bucket
April 11, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Varian Medical Systems, 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

Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.

Z-1324-2013
Recall number
Z-1324-2013
Initiated
April 11, 2013
Classification
Class II
Status
Terminated
Quantity
21 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.

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

Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.

Code information

Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387

Distribution pattern

Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.