Carestream Health, Inc. CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer. Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Brand
Carestream Health, Inc.
Lot Codes / Batch Numbers
Software Verions: 1) 5.7.312.27, 2) 5.7.312.27, 3) 5.7.312.2031
Products Sold
Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031
Carestream Health, Inc. is recalling CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for scre due to Reduced mammographic image quality when attempting to print true size multi-format images. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reduced mammographic image quality when attempting to print true size multi-format images
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NY, NC, OH
Page updated: Jan 10, 2026