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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97046

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 22, 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

2 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 2

Change Healthcare Cardiology Hemo Software

Z-2071-2025
Recall number
Z-2071-2025
Initiated
May 22, 2025
Classification
Class II
Status
Ongoing
Quantity
29 systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software update may cause

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

Due to complaints, software update may cause software to unexpectedly shutdown.

Code information

Software version 14.3.2/UDI: (01)17540262100051/ 15.0.1/UDI: (01)17540262100105

Distribution pattern

Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.

device · product 2 of 2

Change Healthcare Cardiology Hemodynamics Software

Z-2072-2025
Recall number
Z-2072-2025
Initiated
May 22, 2025
Classification
Class II
Status
Ongoing
Quantity
4 systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software update may cause

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

Due to complaints, software update may cause software to unexpectedly shutdown.

Code information

Software version: 15.0.1/UDI: (01)17540262100129

Distribution pattern

Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.