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U.S. Department of Health and Human Services

Class 2 Device Recall Change Healthcare Radiology Solutions

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  Class 2 Device Recall Change Healthcare Radiology Solutions see related information
Date Initiated by Firm August 25, 2020
Create Date October 08, 2020
Recall Status1 Terminated 3 on February 16, 2021
Recall Number Z-0072-2021
Recall Event ID 86401
510(K)Number K140909  
Product Classification System, image processing, radiological - Product Code LLZ
Product Change Healthcare Radiology Solutions 14.0
Code Information All Model number 14.0 UDI (01)17540262030020(10)140000
Recalling Firm/
Manufacturer		 CHANGE HEALTHCARE CANADA COMPANY
10711 Cambie Rd Suite 130
Richmond Canada
Manufacturer Reason
for Recall		 Software defect which may potentially result in one or more images missing in a study
FDA Determined
Cause 2		 Process design
Action 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.
Quantity in Commerce 5 devices
Distribution Domestic distribution to VT, MS, WV, NE
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = MCKESSON MEDICAL IMAGING COMPANY
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