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Carestream Health, Inc. Recall: OnSight 3D Extremity System- X-Ray, Tomography Computed Sy

Carestream Health, Inc. Recall: OnSight 3D Extremity System- X-Ray, Tomography Computed Sy is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Carestream Health, Inc.; Product: OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 174

Recalling firmCarestream Health, Inc.
ProductOnSight 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 recallWhen 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide 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 KINGDO
Recall initiated20190319
Recall numberZ-1207-2019
Categorydevice
StateNY
CountryUnited States

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