Reported May 20, 2015 · Terminated
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
GE Healthcare
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 · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
GE HealthcareCARESCAPE Monitor B850B650 and B450 (Bx50)
- Lot codes and dates
- Mfg Lot or Serial #
110 of 110 codes
SED12394685GASED12394688GASED12404710GASED12404711GASED12404713GASED12404716GASED12404718GASED12404720GASED12404721GASED12404722GASED12404723GASED12404725GASED12445258GASED12445259GASED12445261GASED12445262GASED12445264GASED12445265GASED12445266GASED12445268GASED12445269GASED12445298GASED12445299GASED12445309GASEW12265533HASEW13286489HASEW14095097HASEW14095105HASEW14105496HASEW14105497HASEW14105502HASEW14105503HASEW14160623HASEW14160626HASEW14171213HASEW14171313HASEW14171314HASEW14171315HASEW14171317HASEW14171319HASEW14171320HASEW14171321HASKA14062508GASKA14062511GASKA14284377GASKA14284378GASKA14284382GASKA14284385GASKA14284388GASKA14284393GASKA14284394GASKA14284395GASKA14365356GASKA14365375GASKA14365378GASKA14365380GASKA14365382GASKA14487159GASKA14487160GASKA14487161GA
- Mfg Lot or Serial #
- Amount recalled
- 110 (83 units US, 27 units OUS)
Where it was sold
Why it was recalled
The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patient¿s condition and delayed or missed life sustaining patient treatment
This product could cause temporary or reversible health problems — stop using it.
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