GE Healthcare…

Date posted by the FDA

March 3, 2011

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE Healthcare, ApexPro Telemetry System The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered. The physiological parameters monitored include ECG, noninvasive blood pressure, non-invasive temperature and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro Telemetry System is also intended to provide physiologic data over the Unity Network to clinical information systems for display.

Reason

GE Healthcare has become aware of a potential for loss of patient monitoring when ApexPro Telemetry System is used in conjunction with a mirrored view CARESCAPE CIC Pro in combination monitoring mode (combo mode). The safety issue includes the potential for a delay in annunciation of audible alarms when used in combo mode, and may result in the delay of treatment of a cardiac event.

Distribution pattern

Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT,NE, NJ, NM, NY, NC, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY. and the UNITED KINGDOM, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH KOREA, RUSSIA, NORWAY, NEW ZEALAND, NETHERLANDS, MALAYSIA, JAPAN, ITALY, ISRAEL, IRELAND, GERMANY, FRANCE, FINLAND, DENMARK, CUBA, CHINA, CANADA, AUSTRIA, AUSTRALIA, POLAND.

Quantity

2346

Codes and lots

Parent SN SEE09530903GA SAH04350057GA SAH08423888GA SAH08423889GA SAH08423891GA SAH08423893GA SAH08423894GA SAH08423899GA SAH08423904GA SEE09100090GA SEE09140180GA SEE09140182GA SEE09140185GA SEE09140189GA SEE09140193GA SEE09140196GA B23F1402G F24T0081G SAH08023359GA SEE09360479GA SEE09360481GA SEE09370493GA SEE09370497GA SEE09040063GA SAH07142624GA SAH08203506GA SAH08203528GA SAH08253589GA SAH08253594GA SAH08253595GA SAH08253596GA SAH08253598GA SAH08253599GA SAH08253601GA SAH08253602GA SAH08253603GA SAH08253604GA SAH08403876GA SEE09100130GA SEE09230279GA SAH08443929GA SAH08373782GA SAH06141736GA SAH06141738GA SAH06141740GA SAH06141742GA SAH06141743GA SAH08303681GA SAH08313695GA SEE09530899GA A1GQ0229G AA104340738GA SAH08474000GA SAH08514088GA SEE09410562GA SAH06241958GA SAH06241963GA H34T3477G SAH08524129GA SAH08524132GA SAH08524134GA SAH08494058GA SAH08514087GA F24T0308G F24T0309G SAH08143425GA SAH08173482GA SAH07172678GA SAH07172679GA SAH07172680GA SAH07172681GA SAH07202727GA SAH07202728GA SAH07202729GA SAH08353729GA SAH08383838GA SAH08423923GA SAH07443145GA SAH07052505GA SAH07142633GA SAH07152651GA SAH07202721GA K24T1214G K24T1215G K24T1225G L24T1362G SAH05160818GA SAH05521405GA SAH05521413GA SAH08133423GA SAH08173477GA SAH04490361GA SAH09024176GA SEE09510793GA SEE09510802GA SEE09510808GA L13F0715G SAH06382065GA SAH07403027GA SAH08023331GA SAH08023333GA SAH07172673GA SAH07172674GA SAH07202724GA SAH07232763GA SAH07232765GA SAH07232766GA SAH07232767GA SAH07232778GA SAH07232779GA SAH07232780GA SAH07232781GA SAH07232782GA SAH07232791GA SEE09470676GA SEE09470685GA SEE09490758GA SAH07172676GA SEE10250134GA SEE09340440GA SAH07372943GA SAH07372946GA SAH07372951GA SAH07372954GA SAH07372958GA SAH07372960GA SEE09380531GA SEE09390548GA SEE09020029GA J13F0006G SAH08343707GA SAH08353736GA SAH08353737GA SAH08353739GA SAH08353743GA SAH08363745GA SAH08363747GA SAH08363753GA SEE09410584GA SEE09150220GA SEE09190239GA SEE09190243GA SAH07342937GA SAH07372945GA SAH07372953GA SAH07372959GA SAH07372994GA SAH07372995GA SAH07372996GA SAH07372997GA SAH07372999GA SAH08443940GA SEE09100083GA SEE09100132GA SEE09350463GA SEE09360471GA SAH06382085GA SAH07052504GA SAH07142625GA SAH07423090GA SAH08423914GA D23F1971G D23F1987G J0GQ0014G J0GQ0015G J0GQ0016G J0GQ0020G J0GQ0021G SAH04450260GA SAH04450266GA SAH04450275GA SAH08143427GA SAH08143428GA SAH08143439GA SAH08403849GA SAH08423903GA SAH07443129GA SAH07443135GA SEE09020034GA AA104200139GA SAH05451205GA SAH05451207GA SAH05451211GA SAH05451213GA SAH05451220GA SAH06412134GA SAH07152656GA K24T1033G K24T1039G SEE09140186GA J13F0203G J34T3686G J34T3688G J34T3689G J34T3693G K34T3900G K34T3902G SAH07102599GA SAH08203525GA SAH08203527GA SAH08203530GA SAH08203531GA SAH08213549GA SAH08494007GA SAH08494008GA SEE09530881GA SEE09530887GA B34T2019G B34T2095G D23F1936G M34T4318G SAH05491351GA SAH06241966GA SAH07372948GA SAH08033386GA SAH08203521GA SAH08353735GA SAH08353738GA SAH08353740GA SAH08353741GA SAH08353742GA SAH08353744GA…

Recall started

Jan. 28, 2011

Device type

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

Root cause (FDA)

Software design

What the company told customers

GE sent an "Urgent Medical Device Correction" letter dated December 29, 2010. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Affected Product Details, Product Correction, Safety Instruction and Contact Information. Customers were instructed to contact Technical Support or their local Service Representative with any questions regarding this medical device. For any questions regarding this recall call 262-573-4122.

Recall number

Z-1522-2011

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

Source: FDA · Medical device enforcement report, recall number Z-1522-2011. The agency record governs; check it and the company before acting.