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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77818

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

Open FDA event record

Event summary

Timeline bucket
July 13, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Medical Systems Information Technologies, 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

CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.

Z-0202-2018
Recall number
Z-0202-2018
Initiated
July 13, 2017
Classification
Class II
Status
Terminated
Quantity
1,196 (1,176 US; 20 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.

Code information

Model No. 2042084-001. 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Distribution pattern

Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany.

Field note

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