OnSight 3D Extremity System- X-Ray recall
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device…
Why was OnSight 3D Extremity System- X-Ray recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device…
- Recalling firm
- Carestream Health, Inc.
- Quantity
- 37 units
- 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.
- Recall date
- May 1, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)