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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64812

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

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Event summary

Timeline bucket
March 13, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Masimo Corporation

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

Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

Z-1187-2013
Recall number
Z-1187-2013
Initiated
March 13, 2013
Classification
Class II
Status
Terminated
Recalling firm
Masimo Corporation
Quantity
42,908 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.

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

Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.

Code information

Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194

Distribution pattern

Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.