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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61879

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 12, 2012
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

2 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 2

Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.

Z-0759-2013
Recall number
Z-0759-2013
Initiated
April 12, 2012
Classification
Class II
Status
Terminated
Quantity
344 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

Code information

All lots

Distribution pattern

US Nationwide Distribution

device · product 2 of 2

Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.

Z-0760-2013
Recall number
Z-0760-2013
Initiated
April 12, 2012
Classification
Class II
Status
Terminated
Quantity
152 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

Code information

All lots

Distribution pattern

US Nationwide Distribution