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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85799

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

Open FDA event record

Event summary

Timeline bucket
June 08, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips North America, LLC

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

Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)

Z-2531-2020
Recall number
Z-2531-2020
Initiated
June 08, 2020
Classification
Class II
Status
Terminated
Quantity
46,597 Units WW

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867036).If they are connected to a host monitor, communication with the X3 or MMX could be disrupted, resulting in a loss of monitoring on the host monitor.

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

Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867036).If they are connected to a host monitor, communication with the X3 or MMX could be disrupted, resulting in a loss of monitoring on the host monitor.

Code information

Units with this hardware version can be identified by the following serial number prefix: SN prefix: DE435xxxxx (first five digits)

Distribution pattern

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