Reported Jul 30, 2014 · Terminated
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and…
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. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
- Lot codes and dates
- Mfg Lot or Serial # System ID
2,108 of 2,108 codes
SEW10233202HAM1176021-052037SEW10233203HAM1176021SEW10233204HAM1176021-052037SEW10233206HAM1176021-052037SEW10233209HAM1176021-052037SEW10233210HAM1176021-052037SEW10243447HAM1176021-052037SEW10243449HAM1176021-052037SEW10243450HAM1176021-052037SEW10243458HAM1176021-052037SEW10243476HAM1176021-052037SEW10243477HAM1176021-052037SEW10243478HAM1176021-052037SEW10243479HAM1176021-052037SEW10243481HAM1176021-052037SEW10243482HAM1176021-052037SEW10243484HAM1176021-052037SEW10243486HAM1176021-052037SEW10243487HAM1176021-052037SEW10243489HAM1176021-052037SEW10243490HAM1176021-052037SEW10243491HAM1176021-052037SEW10243492HAM1176021-052037SEW10243496HAM1176021-052037SEW10243499HAM1176021-052037SEW10243500HAM1176021-052037SEW10243503HAM1176021-052037SEW10243504HAM1176021-052037SEW10354687HAM1176021SEW10354688HAM1176021
- Mfg Lot or Serial # System ID
- Amount recalled
- 21,799 (7,635 units US, 14,164 units OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor.
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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