Radiology software recalled because reports may not display fully when viewed
Change Healthcare is recalling 12 programs running Radiology Solutions software version 14.2.2 because a software issue means radiology reports may not be fully displayed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: incompletely displayed radiology reports can lead to clinical decisions based on partial information, and no injuries are reported.
Plain-English summary
Change Healthcare Radiology Solutions software version 14.2.2 is being recalled because, due to a software issue, radiology reports may not be fully displayed when viewing.
The recall covers 12 programs carrying UDI 17540262030068. Distribution was worldwide, including in Arkansas, Wisconsin, New Jersey, Indiana, Alabama, California, Washington, Florida, Massachusetts and Louisiana. The FDA has classified the action as Class II.
A report that does not display in full could leave a reader working from incomplete information. Sites running version 14.2.2 should follow the firm's instructions and verify report completeness against the source until the issue is corrected.
The recalled product
- Product
- Change Healthcare Radiology Solutions software version 14.2.2
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Version 14.2.2/UDI: (01)17540262030068
Distribution
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