CARESCAPE MONITOR B850 Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor…

Date posted by the FDA

Aug. 25, 2010

Status

Terminated

Filed by

GE Healthcare, LLC

Product

CARESCAPE MONITOR B850 Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.

Reason

GE Healthcare has become aware of four potential safety issues associated with the CARESCAPE" Monitor B850: 1. Loss of user input when using certain displays or the USB remote control. 2. Potential for a delay in treatment or missed alarm when the alarm light is used as a primary alarm source and audible alarms are turned down or off. 3. The CARESCAPE Monitor B850 will not use user entered hemo

Distribution pattern

CA, CO, FL, GA, KY, LA, MA, MI, NE, NJ, NY, NC, OH, OR, PA, TX VA, and WI, Foreign: UNITED KINGDOM, TURKEY, SWITZERLAND, SPAIN , SLOVENIA, SINGAPORE, SAUDI ARABIA, PORTUGAL NETHERLAND, ITALY, GERMANY, FRANCE,FINLAND, DENMARK, CZECH REPUBLIC, BELGIUM, AUSTRIA, and AUSTRALIA.

Quantity

875

Codes and lots

Parent Serial Number SED10102064GA SED10102074GA SED10102077GA SED10102078GA SED10102087GA SED10102088GA SED10102089GA SED10102094GA SED09441082GA SED10021717GA SED10021718GA SED10021722GA SED10031770GA SED10031772GA SED10031776GA SED09451341GA SED09471459GA SED09471460GA SED09471461GA SED09471463GA SED09471464GA SED09471467GA SED09471468GA SED09471469GA SED09471470GA SED09471472GA SED09471474GA SED09471476GA SED09471480GA SED09471481GA SED09471486GA SED09471488GA SED09471491GA SED09471493GA SED09471496GA SED09471478GA SED09491583GA SED09491587GA SED09491595GA SED09491596GA SED09491597GA SED09491599GA SED09511674GA SED09511676GA SED10021713GA SED09451339GA SED09451340GA SED10061886GA SED09400941GA SED09400945GA SED09400948GA SED10021730GA SED10031735GA SED10031744GA SED10031749GA SED10071894GA SED10071896GA SED10071901GA SED10071902GA SED10071903GA SED10071904GA SED10071907GA SED10071913GA SED10071914GA SED10071916GA SED10071920GA SED10071921GA SED10071931GA SED10071937GA SED10081947GA SED10081955GA SED10081956GA SED10081959GA SED10081961GA SED10081962GA SED10081964GA SED10081965GA SED10081966GA SED10081969GA SED10081973GA SED10081976GA SED10081981GA SED10081984GA SED10081985GA SED10081986GA SED10081988GA SED10081989GA SED10081990GA SED10081994GA SED10081995GA SED10081997GA SED10082004GA SED10082007GA SED10082008GA SED10082009GA SED10082011GA SED10082012GA SED10082015GA SED10082016GA SED10082018GA SED10082019GA SED10082020GA SED10082021GA SED10082022GA SED10092030GA SED10092032GA SED10102082GA SED10102083GA SED10212790GA SED10212791GA SED10212792GA SED10212793GA SED10212794GA SED10212795GA SED10071918GA SED10082013GA SED10092038GA SED10102053GA SED10112141GA SED10112151GA SED10112161GA SED10112175GA SED10112182GA SED10112193GA SED10112194GA SED10112195GA SED10112196GA SED10112197GA SED10112247GA SED10112248GA SED10112258GA SED10112261GA SED10112264GA SED10122298GA SED10122300GA SED10122308GA SED10122336GA SED10132449GA SED10132450GA SED10132453GA SED10132456GA SED10132458GA SED10132462GA SED10132464GA SED10122318GA SED10122352GA SED10122361GA SED10122363GA SED10122365GA SED10122371GA SED10122372GA SED10122373GA SED10122375GA SED10122376GA SED10122377GA SED09451348GA SED09471462GA SED10132382GA SED10132386GA SED10132390GA SED10132400GA SED10132404GA SED10132405GA SED10132406GA SED10132411GA SED10132416GA SED10132419GA SED10132431GA SED09330576GA SED10132420GA SED09451343GA SED09451376GA SED09451345GA SED09491601GA SED10112270GA SED10122299GA SED09451344GA SED09451346GA SED09471494GA SED09511667GA SED09451342GA SED09491600GA SED09491603GA SED09471487GA SED09370830GA SED09390846GA SED09390850GA SED09390852GA SED09390862GA SED09390863GA SED09390864GA SED09390865GA SED09390866GA SED09390869GA SED09390870GA SED09390873GA SED09390875GA SED09390878GA SED09390880GA SED09390881GA SED09390884GA SED09390885GA SED09390886GA SED09390887GA SED09390888GA SED09390889GA SED09390893GA SED09400897GA SED09400898GA SED09400899GA SED09400900GA SED09400901GA…

Recall started

July 16, 2010

Device type

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Root cause (FDA)

Software design

What the company told customers

Consignees were sent on 7/16/10, a GE "Urgent Medical Device Correction" letter dated July 12, 2010. The letter was addressed to Healthcare Administrator/Risk Manger, Chief of Nursing, Director of Biomedical Engineering. They stated the Safety Issues, Affected Product Details, Product Correction, Safety Instructions and Contact Information. If you have any questions, please contact Technical Support at 1-800-558-7044.

Recall number

Z-2275-2010

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2275-2010. The agency record governs; check it and the company before acting.