FDAFDA · Food and drugs·Recall number Z-1207-2019
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.
Published May 1, 2019 · Recall initiated: March 19, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carestream Health, Inc.
- Distributor
- 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.
- Lot
- US Serial Numbers: 58008585 58007506 58000020 58008493 58000015 58007502 58007504 58008494 58007503 58008018 58007505 58008500 58008011 58008014 OUS: 10012 20005 20012 20016 20007 20017 10018 10004 10007 20004 20008 10023 10009 20019 20013 10002 10003 10014 10010 20006 20022 20003 20010
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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