Carestream Health, Inc. recalls OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574

Recalled May 1, 2019 · FDA recall Z-1207-2019 · Carestream Health

Hazard

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. · FDA Class II

Units

37 units

Sold at

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.

Description

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.

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.

Manufacturer(s)

Carestream Health, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →