Change Healthcare Radiology Solutions 14.0
- Company
- Change Healthcare Canada Company
- Recall Initiated
- August 25, 2020
- Terminated
- February 16, 2021
- Recall Number
- Z-0072-2021
- Quantity
- 5 devices
- Firm Location
- Richmond Canada
Reason for Recall
Software defect which may potentially result in one or more images missing in a study
Distribution
Domestic distribution to VT, MS, WV, NE
Lot / Code Info
All Model number 14.0 UDI (01)17540262030020(10)140000
Root Cause
Process design
Action Taken
Change Healthcare Canada Company issued Urgent Field Safety Notice on 08/25/2020. It states the following: 1. The customer should ensure radiologists and technologists are aware of the potential that the study may be missing images or DICOM objects, so that they carefully review any study where the above listed situations may be present in the workflows. 2. Change Healthcare has identified a configuration change that will prevent the deletion of impacted images. The customer should contact Change Healthcare Customer Support to ensure this configuration is place. Recommended actions to take on potentially affected data: Change Healthcare strongly encourage customers receiving this Urgent Field Safety Notice to immediately contact Change Healthcare Customer Support to: 1) Acknowledge they have read and understood this Urgent Field Safety Notice, and 2) Arrange the configuration change, and 3) Arrange the installation of software update. Change Healthcare Customer Support for US/Canada: 1-800-663-2553 This notice must be distributed to all personnel within your organization who need to be aware of this Urgent Field Safety Notice. Customers should alert other affiliated parties that may be affected by this Urgent Field Safety Notice. To ensure effectiveness of any required corrective actions, please maintain awareness of this Urgent Field Safety Notice until the issue has been fully resolved.