Z-0072-2021Class II

Change Healthcare Radiology Solutions 14.0

Name: Z-0072-2021 Change Healthcare Radiology Solutions 14.0
Creator: Change Healthcare Canada Company
Published: 2020-08-25
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2020-08-25 / Terminated / root cause: manufacturing process

FDA source

CHANGE HEALTHCARE CANADA COMPANY began a recall of Change Healthcare Radiology Solutions 14.0 on 2020-08-25. FDA classified it as Class II and gives the reason as "Software defect which may potentially result in one or more images missing in a study". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0072-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-25
Posted: 2020-10-08
Terminated: 2021-02-16
Recalling firm: Change Healthcare Canada Company
Product: Change Healthcare Radiology Solutions 14.0
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software defect which may potentially result in one or more images missing in a study
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: All Model number 14.0 UDI (01)17540262030020(10)140000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0072-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0072-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08

Product code LLZ

K140909Class IIMckesson RadiologyMckesson Medical Imaging Company / cleared 2014-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)