PlainRecordsAmbra PACS…
- 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.
- Status
- Ongoing
- 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.
- Enforcement report date
- Oct. 5, 2022
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- DICOM Grid, Inc. d/b/a Ambra Health
- 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.
- Distribution pattern
- 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.
- Quantity
- 671 downloads
- Codes and lots
- UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0.
- Recall started
- June 23, 2022
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- System, Image Processing, Radiological
- Root cause (FDA)
- Software design
- What the company told customers
- The firm distributed an Urgent Medical Device Recall Notice dated June 23, 2022, by email to affected customers. The firm informed customers that a race condition was identified between Ambra's storage system and the serivces database which has the potential to revert edits made to patient health information upon first ingestion of a study. This could lead to a possibility that incorrect patient ifnormation is presented to the physician, which would impact the decision making in regard to patient care. Customers are asked to advise all users of the system of this issue, request a patch from Ambra to be enabled on your system, and wait until all images for a given study are ingested before manually editing patient health information in the study. Ambra's actions include the deployment of a patch that is acting as a temporary fix until a software update can be deployed to all customers, which will prevent the issue from occurring in the future.
- Recall number
- Z-1818-2022
What this record is about
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“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.”Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images., FDA enforcement report, 2022-10-05. The caption is the record's own words.
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FDA device name: System, Image Processing, Radiological
Distributed in (FDA's record): Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maryland Massachusetts Michigan Minnesota Mississippi Missouri Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina Tennessee Texas Utah Virginia Washington West Virginia Wisconsin
This recall among the others
- FDA's enforcement report came 104 days after the firm started the recall. For half of the 888 FDA medical device recall events reported in 2022 with a start date, it took 54 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-1818-2022. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1818-2022, Oct. 5, 2022. "Ambra PACS." PlainRecords, https://plainrecords.com/recall/device/z-1818-2022/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections