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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87829

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

Open FDA event record

Event summary

Timeline bucket
February 02, 2021
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

IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

Z-1671-2021
Recall number
Z-1671-2021
Initiated
February 02, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices

Code information

Serial numbers: US09699788 (US) US156J6219 (US) US156J3658 (OUS) UDI: (01)00884838082236 (21)US09699788 (01)00884838082236 (21)US156J6219 (01)00884838030350 (21)US156J3658

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.