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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66946

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

Open FDA event record

Event summary

Timeline bucket
December 20, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, 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

CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel.

Z-0927-2014
Recall number
Z-0927-2014
Initiated
December 20, 2013
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
12, 945 units (6,239 US, 6,706 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. The PDM patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the F5-01 Frame due to an issue with the PDM Ethernet communication hardware. The communicatio

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. The PDM patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the F5-01 Frame due to an issue with the PDM Ethernet communication hardware. The communicatio

Code information

serial numbers: SEG09270517HX, SEG09270549HX, SEG09270551HX, SEG09270553HX, SEG09270554HX, SEG09270557HX, SEG09270559HX, SEG09270561HX, SEG09270562HX, SEG09270563HX, SEG09270564HX, SEG09270565HX, SEG09270566HX, SEG09270567HX, SEG09270568HX, SEG09270569HX, SEG09270583HX, SEG09270584HX, SEG09270585HX, SEG09270587HX, SEG09270588HX, SEG09270589HX, SEG09270591HX, SEG09270592HX, SEG09280596HX, SEG09280597HX, SEG09280598HX, SEG09280599HX, SEG09280600HX, SEG09280601HX, SEG09280602HX, SEG09280603HX, SEG09280604HX, SEG09280605HX, SEG09280606HX, SEG09280607HX, SEG09280608HX, SEG09280609HX, SEG09280610HX, SEG09280611HX, SEG09280612HX, SEG09280613HX, SEG09280614HX, SEG09280615HX, SEG09280616HX, SEG09280617HX, SEG09280618HX, SEG09280619HX, SEG09280620HX, SEG09280621HX, SEG09280622HX, SEG09280623HX, SEG09280624HX, SEG09280625HX, SEG09310656HX, SEG09310657HX, SEG09310658HX, SEG09310659HX, SEG09310660HX, SEG09310661HX, SEG09310662HX, SEG09310663HX, SEG09310664HX, SEG09310665HX, SEG09310666HX, 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Distribution pattern

Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Australia, Austria, Azerbaijan, Bahrain, Belgium, BRAZIL, Canada, CHILE, COSTA RICA, Cyprus, Czech Republic, Denmark, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, GUAM, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Republic of, Kuwait, Lithuania, Malaysia, Malta, Mexico, NEPAL, Netherlands, New Zealand, Norway, Pakistan, PANAMA, PARAGUAY, PERU, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, United Republic of, Turkey, United Arab Emirates, United Kingdom, URUGUAY.