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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83342

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

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Event summary

Timeline bucket
July 03, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Xcision Medical Systems, LLC

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

GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.

Z-2081-2019
Recall number
Z-2081-2019
Initiated
July 03, 2019
Classification
Class II
Status
Terminated
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.

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

One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.

Code information

Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005

Distribution pattern

The products were distributed to the following US states: MD and TX.