Change Healthcare Radiology Solutions recallZ-0072-2021 · Change Healthcare Canada Company · initiated Aug 25, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Change Healthcare Canada Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software defect which may potentially result in one or more images missing in a study
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-0072-2021
- Status
- Terminated
- Initiated by the company
- Aug 25, 2020
- Recalling firm
- Change Healthcare Canada Company
- Quantity
- 5 devices
- Product code
- LLZ
- FDA submissions
- K140909
- Distribution
- Domestic distribution to VT, MS, WV, NE
Product description
Change Healthcare Radiology Solutions 14.0
Code information (models, lots, serial numbers)
All Model number 14.0 UDI (01)17540262030020(10)140000
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Change Healthcare Radiology Solutions 14.0Change Healthcare Canada Company · System, Image Processing, Radiological2 recalls1 report
Product lines
Other devices under the same FDA submission
1 device cleared under K140909 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Change Healthcare Radiology Solutions 14.2.2Change Healthcare Canada Company · System, Image Processing, Radiological1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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