FDA Medical Device Recalls (openFDA)
Carestream Health, Inc.: 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.
- Recall number
- Z-1207-2019
- Recalling firm
- Carestream Health, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2019-03-19
- Posted
- not on file
- Terminated
- 2020-04-27
- Reason
- 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.
- Root cause
- Software design
- Action
- Carestream issued a "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 15, 2019 on March 19, 2019 via USPS Certified Mail Return Receipt Requested, describing problem, risk to health and corrective action. Carestreams representative will contact to schedule a convenient date and time within the next 6 months to install the software update. In the meantime, please use extreme caution to ensure proper reassignment of both parent and companion volumes whenever reassignment to a different patient is required. Also complete and return the Consignee Notification Acknowledgement form by e-mail to: postmarketra@carestream.com. If you have distributed the device outside your facility, please alert your customer(s) of this field correction and contact the Carestream Customer Care Center as instructed above. Questions or concerns, contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call the local Carestream Service support number.
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K173478"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1317307
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28