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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84551

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

Open FDA event record

Event summary

Timeline bucket
December 12, 2019
Product types
Device
Classifications
Class I
Statuses
Completed
Recalling firm wording
ResMed Ltd.

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

ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150

Z-0915-2020
Recall number
Z-0915-2020
Initiated
December 12, 2019
Classification
Class I
Status
Completed
Recalling firm
ResMed Ltd.
Quantity
69

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software and a component failure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch.

Code information

Serial Number Range: 20160123307 to 22171057208

Distribution pattern

U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT