Reported Sep 25, 2013 · Terminated
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use…
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?
- GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, ECU diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (HI1S) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 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. The CARESCAPE Monitor B650 is not intended for use during MRI.
- Lot codes and dates
- Parent SN
2,173 of 2,173 codes
SEW10233202HASEW10233203HASEW10233204HASEW10233206HASEW10233209HASEW10233210HASEW10243447HASEW10243449HASEW10243450HASEW10243458HASEW10243476HASEW10243477HASEW10243478HASEW10243479HASEW10243481HASEW10243482HASEW10243484HASEW10243486HASEW10243487HASEW10243489HASEW10243490HASEW10243491HASEW10243492HASEW10243496HASEW10243498HASEW10243499HASEW10243500HASEW10243503HASEW10243504HASEW10354687HASEW10354688HASEW10354694HASEW10354695HASEW10354696HASEW10354697HASEW10354701HASEW10354704HASEW10354706HASEW10354707HASEW10354708HASEW10354709HASEW10354712HASEW10354713HASEW10354717HASEW10354722HASEW10354724HASEW10354728HASEW10354730HASEW10354736HASEW10354738HASEW10354740HASEW10354741HASEW10354746HASEW10354749HASEW10354751HASEW10354752HASEW10354754HASEW10354756HASEW10354757HASEW10354758HA
- Parent SN
- Amount recalled
- 9466 (3261 US, 6205 OUS)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported.
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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