# FDA recall Z-1207-2019

> **Carestream Health, Inc.** · Class II · device recall initiated 2019-03-19.

## Product

OnSight 3D Extremity System- X-Ray, Tomography Computed System  Catalog Numbers:  1743566 (w/ Attached Console)  1743574 (w/ Remote Console)    The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.

## Reason for recall

When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.

## Distribution

Worldwide Distribution: US (nationwide) to states of: Arizona, California, New York, Alabama, Georgia, Georgia, Illinois, Minnesota, New York, Oregon, Pennsylvania; and countries of: IRAN, ITALY, JERUSALEM, KOREA, PHILIPPINES, PORTUGAL,SAUDI ARABIA, SINGAPORE, SWITZERLAND  THAILAND, and UNITED KINGDOM.

## Key facts

- **Recall number:** Z-1207-2019
- **Recalling firm:** Carestream Health, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-19
- **Report date:** 2019-05-01
- **Termination date:** 2020-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1207-2019

## Citation

> AI Analytics. FDA recall Z-1207-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1207-2019. Source: US FDA. Licensed CC0.

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