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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83889

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

Open FDA event record

Event summary

Timeline bucket
September 13, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Draegar Medical Systems, Inc.

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

The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.

Z-0258-2020
Recall number
Z-0258-2020
Initiated
September 13, 2019
Classification
Class II
Status
Ongoing
Quantity
5634

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Cybersecurity vulnerabilities

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

Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.

Code information

Software version VG4.1.1/VG4.0.3 and lower

Distribution pattern

US Nationwide distribution.