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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90817

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 23, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
DICOM Grid, Inc. d/b/a Ambra Health

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.

Z-1818-2022
Recall number
Z-1818-2022
Initiated
June 23, 2022
Classification
Class II
Status
Ongoing
Quantity
671 downloads

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0.

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.