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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89243

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

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Event summary

Timeline bucket
December 16, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Draeger Medical, 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

Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300

Z-0501-2022
Recall number
Z-0501-2022
Initiated
December 16, 2021
Classification
Class II
Status
Terminated
Recalling firm
Draeger Medical, Inc.
Quantity
5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.

Code information

UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002

Distribution pattern

US Nationwide distribution in the states of NY, PA, and WI.