Reported Oct 17, 2018 · Ongoing
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries…
GE Healthcare Finland Oy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare Finland Oy · Kuortaneenkatu 2 · Helsinki · N/A
Is this the product you have?
- GE Healthcare
- CARESCAPE Monitor B850 Product UsageIntended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. 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 is indicated for monitoring of-hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation). -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange) and -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission. The CARESCAPE Monitor B850 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices
- Lot codes and dates
- Serial NumbersNo
- UDI
2,172 of 2,172 codes
SKA14365373GASKA16085338SASKA16085415SASED11178711GASED11178722GASED11178730GASED11178731GASED12384211GASKA16065074SASKA16065096SASKA16105698SASKA16105700SASED11148380GRSED11168558GRSED11229587GRSED12183123GASED12183126GASED12273483GASED12353647GASED12353648GASED12363714GASED12363728GASED12373928GASED09320537GASED11300215GRSED11300224GRSED11300285GRSED11300317GRSED11300318GRSED11420905GRSED11420906GRSED11420913GRSED11420919GRSED11420923GRSED11420926GRSED11420927GRSED11420928GRSED11420929GRSED11420930GRSED11420931GRSED11430946GRSED11430947GRSED11430949GRSED11430967GRSED11430970GRSED11430971GRSED12152834GRSED12152838GRSED12203208GRSED12203211GRSED12203212GRSED12203213GRSED12203254GRSED12203257GRSED12203258GRSED12203259GRSED12253445GRSED12263455GRSKA14365468GASED11097478GR
- Amount recalled
- 47,937 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
This product could cause temporary or reversible health problems — stop using it.
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