CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Radiology Solutions 14.0 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Software defect which may potentially result in one or more images missing in a study

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

MS, NE, VT, WV