Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92704

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

Open FDA event record

Event summary

Timeline bucket
July 12, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.

Z-2256-2023
Recall number
Z-2256-2023
Initiated
July 12, 2023
Classification
Class II
Status
Ongoing
Quantity
108 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.

Code information

Software version VA20A. (a) Serial numbers 100201, 100202, 100203, 100204, 100205, 100206, 100207, 100209, 100208, 100210, 100212, 100211, 100213, 100215, 100217, 100219, 100218, 100220, 100221, and 100224; UDI-DI 4056869264745. Additional serial numbers as of 09/07/2023: 100223, 100225, 100227, 100228, 100237; Additional serial numbers as of 10/17/2023: 100214, 100229; Additional serial numbers as of 12/12/2023: 100232, 100231, 100234; Additional serial number as of 01/15/2024:100226. (b) Serial numbers 100101, 100102, 100201, 100203, 100204, 100207, 100206, 100208, 100205, 100209, 100210, 100212, 100213, 100214, 100215, 100216, 100218, 100217, 100219, 100220, 100221, 100223, 100224, 100222, 100226, 100228, 100227, 100225, 100229, 100231, 100232, 100233, 100235, 100234, 100237, 100239, 100241, 100240, 100236, 100238, 100242, 100243, 100247, 100244, 100250, 100251, 100252, and 100255; UDI-DI 4056869264752; Additional serial numbers as of 09/07/2023: 100245, 100256, 100257, 100258, 100261, 100262, 100265, 100273; Additional serial numbers as of 10/17/2023: 100230, 100266; Additional serial numbers as of 12/12/2023: 100269; Additional serial numbers as of 01/15/2024: 100248, 100254, 100260, 100271, 100272. (c) Serial numbers 100101, 100201, 100203, 100202, 100205, and 100206; UDI-DI 4056869264769; Additional serial numbers as of 09/07/2023: 100208, 100210; Additional serial numbers as of 12/12/2023: 100209

Distribution pattern

Distribution was made to ID, KS, MA, NH, OH, TX, and VA. There was no government/military distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Canada, Colombia, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Switzerland, Turkey, United Arab Emirates, and United Kingdom.