Recall Z-1207-2019— Carestream Health, Inc.
Class II · Terminated
Class II FDA medical device recall by Carestream Health, Inc., initiated 2019-03-19, terminated 2020-04-27. It names one FDA 510(k) clearance: K173478. 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.. 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..
- Recalling firm
- Carestream Health, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-19
- Terminated
- 2020-04-27
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.