# FDA recall Z-2256-2023

> **Siemens Medical Solutions USA, Inc.** · Class II · device recall initiated 2023-07-12.

## Product

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.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-2256-2023
- **Recalling firm:** Siemens Medical Solutions USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-12
- **Report date:** 2023-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hoffman Estates, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2256-2023

## Citation

> AI Analytics. FDA recall Z-2256-2023. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2256-2023. Source: US FDA. Licensed CC0.

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