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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75052

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

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Event summary

Timeline bucket
July 08, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Elekta, 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

Medical Linear Accelerator

Z-2721-2016
Recall number
Z-2721-2016
Initiated
July 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Elekta, Inc.
Quantity
553

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

Code information

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Distribution pattern

AL, AZ, CA, FL, GA, KY, MI, MN, MO, NE, NJ, NY, NC, OH, OK, PA, SC, TX, WA, WV, Argentina, Austria, Australia, Bosnia and Herzegovinia, Bangladesh, Belgium, Bulgaria, Brazil, China, Columbia, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iran, Italy, Japan, Jordan, Lebanon, Libya, Morocco, Mexico, Nigeria, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Portugal, Serbia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, Yemen

Field note

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