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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78086

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

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Event summary

Timeline bucket
September 18, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions USA, 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

Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.

Z-0047-2018
Recall number
Z-0047-2018
Initiated
September 18, 2017
Classification
Class II
Status
Terminated
Quantity
16 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The torque wrench used to tighten system bolts during installation was found to be out of tolerance

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The torque wrench used to tighten system bolts during installation was found to be out of tolerance

Code information

Symbia T2 serial number 2001; Symbia Intevo Excel serial numbers 2112 and 2140; Symbia Intevo 16 serial numbers 2100 and 2116; Symbia Evo serial numbers 1049, 1054, 1071, 1075, 1104, and 1128; and Symbia Evo Excel serial numbers 1109, 1111, 1131, 1134, and 1158.

Distribution pattern

Distribution was made to medical facilities located in CA, FL, GA, LA, NY, PA, and TN. There was government distribution but no foreign/military distribution.