Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Summary
The FDA issued a Class II for Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analy by DICOM Grid, Inc. d/b/a Ambra Health. Reason: A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion o.
Details
Source
Device Recall
External ID
Z-1818-2022
Action Date
2022-10-05
Status
Ongoing
Category
device
Product Description
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Lot/Code Info: UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0.
Quantity Affected: 671 downloads
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.
Distribution
Domestic: AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, DC, & PR.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-23
Company
New York, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DICOM Grid, Inc. d/b/a Ambra Health) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DICOM Grid, Inc. d/b/a Ambra Health have FDA actions?
This is the only FDA action we have on record for DICOM Grid, Inc. d/b/a Ambra Health in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1818-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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