Exact FDA event identifier

Event 97545

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

Open FDA event record

Event summary

Timeline bucket: August 13, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: CHANGE HEALTHCARE CANADA COMPANY

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

Change Healthcare Radiology Solutions software version 14.2.2

Z-0030-2026

Recall number: Z-0030-2026
Initiated: August 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: CHANGE HEALTHCARE CANADA COMPANY
Quantity: 12 programs

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

software issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to software issue, radiology reports may not be fully displayed when viewing.

Code information

Version 14.2.2/UDI: (01)17540262030068

Distribution pattern

Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.