Recall Z-1818-2022— DICOM Grid, Inc. d/b/a Ambra Health
Class II · Ongoing
Class II FDA medical device recall by DICOM Grid, Inc. d/b/a Ambra Health, initiated 2022-06-23. It names one FDA 510(k) clearance: K202335. Product: Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.. Reason: 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..
- Recalling firm
- DICOM Grid, Inc. d/b/a Ambra Health
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-23
- Firm location
- New York, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.