# FDA recall Z-2655-2017

> **Shimadzu Medical Systems Usa Com** · Class II · device recall initiated 2017-05-23.

## Product

SHIMADZU FDR Visionary   Catalog Number: FDR Visionary Suite  Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals

## Reason for recall

Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

## Distribution

Worldwide Distribution - Nationwide distribution to AK, AR, AZ, CA, CT, FL, IL, IN, KS, LA, MI,  MO, NE, NJ, NM, NV, NY,OH, OK, PA, RI, SC, TN, TX, WA, WI, and Hawaii  Foreign:  Canada and Japan

## Key facts

- **Recall number:** Z-2655-2017
- **Recalling firm:** Shimadzu Medical Systems Usa Com
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-23
- **Report date:** 2017-07-05
- **Termination date:** 2019-10-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Torrance, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2655-2017

## Citation

> AI Analytics. FDA recall Z-2655-2017. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2655-2017. Source: US FDA. Licensed CC0.

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