Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93451

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

Open FDA event record

Event summary

Timeline bucket
November 01, 2023
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 Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.

Z-0551-2024
Recall number
Z-0551-2024
Initiated
November 01, 2023
Classification
Class II
Status
Ongoing
Quantity
454

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's 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

Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.

Code information

Version 1.4, UDI (01)17540262160093(10)010400

Distribution pattern

US Nationwide distribution. There was no military/government distribution.