Diagnostic imaging software may lose patient information edits during processing
Ambra PACS and ProViewer versions 3.22.2.0 and 3.22.3.0 have a software defect where patient information edits may be lost during initial study processing due to a race condition between database systems.
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: FDA Class II recall affecting patient information integrity in diagnostic imaging software. The source identifies a risk-of-harm condition (potential data loss) in a medical device with no reported illnesses, injuries, or confirmed data loss, meeting Score 3 criteria.
Plain-English summary
Ambra PACS and Ambra ProViewer are software tools used by healthcare facilities to view and analyze diagnostic medical images. The FDA has issued a Class II recall for versions 3.22.2.0 and 3.22.3.0 of this software.
A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study. This means that changes healthcare professionals make to diagnostic imaging data during initial processing may be lost.
The software has been downloaded 671 times. It is distributed across the United States, including all 50 states, Washington D.C., and Puerto Rico.
Healthcare facilities and individuals using the affected software versions should contact DICOM Grid, Inc. d/b/a Ambra Health for information on obtaining an updated version of the software.
The recalled product
- Product
- Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
- Manufacturer
- DICOM Grid, Inc. d/b/a Ambra Health
- Affected units
- 671
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 (2)
- UDI-DI: AMBRHEALTHSOLUTIONS0
- Software Version: 3.22.2.0 and 3.22.3.0.
Distribution
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