Reported Jul 3, 2013 · Terminated
CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor…
GE Healthcare, LLC
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, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- CARESCAPE Monitor B850 Product UsageThe CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system is indicated for monitoring of Hemodynamics, Airway Gases (Fi/Et CO2, O2, N2) and Anesthetic Agent), Spirometry, Gas Exchange (O2 Consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. It is a stand-alone monitor or interfaced to other devices. is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI
- Lot codes and dates
- Mfg Lot or Serial #
2,171 of 2,171 codes
SED11107648GASED11107652GASED11117927GASED11117959GASED11168563GASED10293123GASED10293124GASED10353742GASED10353743GASED10132473GASED10303335GASED10333640GASED11178619GASED10142532GASED10485114GASED09340621GASED09340629GASED09340640GASED09340654GASED09340655GASED09471473GASED10021715GASED10021720GASED10041824GASED10112150GASED10112155GASED10112156GASED10112165GASED10112173GASED10112199GASED10122287GASED10122288GASED10122291GASED10122297GASED10122314GASED10122331GASED10122332GASED10122334GASED10122335GASED09090248GPSED09130299GPSED09130301GPSED09130304GPSED09130308GPSED09130309GPSED09130310GPSED09130313GPSED09491635GASED10505510GASED11067055GASED11077158GASED11077165GASED11087325GASED11087333GASED11087361GASED11097434GASED11097448GASED11097449GASED11097455GASED11097498GA
- Mfg Lot or Serial #
- Amount recalled
- 12,779
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
Why it was recalled
GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB communication, CARESCAPE Monitor B850 remote printing issue with currently printing PRN 50 recorder and CARESCAPE Monitor B850 reboots due to an X server freeze.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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