Recall Z-1207-2019 ยท JAK System, X-Ray, Tomography, Computed
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.
| Date | Mar 19, 2019 |
| Status | Terminated |
| 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-mai |
| 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 KINGDO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173478 | OnSight 3D Extremity System Carestream Health, Inc., Jan 19, 2018 |