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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66121

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

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Event summary

Timeline bucket
August 09, 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

VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA

Z-0065-2014
Recall number
Z-0065-2014
Initiated
August 09, 2013
Classification
Class II
Status
Terminated
Quantity
3 sets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.

Code information

Lots #6078184-1, #6078184-2, #6078184-4

Distribution pattern

Worldwide distribution: US (nationwide) distribution in CA and in the country of India.