GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module

Date posted by the FDA

Nov. 15, 2010

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module.

Reason

Transport Pro Monitor stops communication with the CARESCAPE Patient Data Module (PDM) after 414 days of continuous run time. This time will equate to different amounts of real time depending on how much the units is actually in service per day. Transport Pro contains an internal timer that is used to control the software and remind users to perform preventive maintenance. When this internal timer

Distribution pattern

Worldwide Distribution: Domestic in the states of AL, AZ, AR, CA,CT, CO, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, ME, MI, MN, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, VT, WA, WI, and WY, and Internation in the countries of BRAZIL, BERMUDA, BELGIUM, AUSTRIA, AUSTRALIA, CANADA, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY GREECE, INDONESIA, IRELAND, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MAURITIUS, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, REPUBLIC OF KOREA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD 7 TOBAGO, and the UNITED KINGDOM.

Quantity

3256

Codes and lots

Parent SN AAD05390701GA AAD05390702GA AAD05390703GA AAD05390704GA AAD05390705GA AAD05390706GA AAD06031132GA AAD06031137GA AAD06131461GA AAD06131462GA AAD06131466GA AAD06131468GA AAD06131472GA AAD06171539GA AAD06221773GA AAD06221776GA AAD06221777GA AAD06251813GA AAD06251830GA AAD06251851GA AAD06251853GA AAD06251856GA AAD06251857GA AAD06261923GA AAD06261927GA AAD06281937GA AAD06362122GA AAD06372145GA SCS06500630GA SCS06500645GA SCS06500649GA SCS06500661GA SCS06500663GA SCS07010713GA SCS07080892GA SCS07080901GA SCS07201199GP SCS07201200GP SCS07201201GP SCS07201202GP SCS07201203GP SCS07201204GP SCS07201205GP SCS07201206GP SCS07201207GP SCS07281360GP SCS07281361GP SCS07281362GP SCS07281363GP SCS07281364GP SCS07281365GP SCS07281366GP SCS07281367GP SCS07281368GP SCS07281369GP SCS07281370GP SCS07281371GP SCS07281372GP SCS07281373GP SCS07281374GP SCS07391691GA SCS07441939GA SCS08383087GA SCS07482026GA SCS08493368GA SCS08493387GA SCS07221315GA SCS07221316GA SCS07221317GA SCS07221322GA SCS07361513GA SCS07361519GA SCS09464289GA SCS08352985GA SCS08352989GA SCS08362994GA SCS08362997GA SCS08362998GA SCS08363002GA SCS08363009GA SCS08363010GA SCS08363011GA SCS08363012GA SCS08363013GA SCS08363015GA SCS08363017GA SCS08363018GA SCS08363024GA SCS08423226GA SCS08122513GA SCS08142588GA SCS08142590GA SCS08142595GA SCS08142597GA SCS08162602GA SCS08292852GA SCS08292856GA SCS06440374GA AAD06261865GA AAD06261879GA AAD06362136GA AAD06362142GA AAD06372146GA AAD06372160GA AAD06372162GA AAD06372163GA AAD06372165GA SCS07371545GA SCS07371547GA SCS07461979GA SCS08132536GA SCS09173726GA AAD06031155GA AAD05430764GA AAD05430776GA AAD05430777GA SCS08393161GA SCS08413170GA SCS08413173GA SCS07080875GA SCS07080884GA SCS07080907GA SCS07391631GA SCS07391683GA SCS09474313GA SCS09474319GA SCS09474327GA SCS09303900GA SCS08172648GA SCS08192660GA SCS08192662GA SCS08202677GA SCS08202678GA SCS08212695GA SCS08212698GA SCS08212699GA SCS08473302GA SCS08473306GA SCS08473307GA SCS08473308GA SCS08473310GA SCS08473313GA SCS08473321GA SCS08473325GA SCS08473327GA SCS08473331GA SCS09454267GA SCS09474338GA SCS09153713GA SCS09173719GA SCS09333987GA SCS09333988GA SCS09333989GA SCS09333990GA SCS09333991GA SCS09333992GA SCS09333993GA SCS09333995GA SCS09333996GA SCS09333997GA SCS09424201GA SCS09424202GA SCS09263820GA SCS09263821GA SCS09263822GA SCS09263823GA SCS09263824GA SCS09263825GA SCS09263828GA SCS07431852GA AAD05240213GA AAD05310398GA AAD05310399GA AAD05310400GA AAD05310401GA AAD05310402GA AAD05310403GA AAD05310404GA AAD05310405GA AAD05430743GA AAD05430744GA AAD05430797GA AAD05430798GA AAD05521016GA AAD05521017GA AAD06171503GA AAD06171511GA AAD06171512GA AAD06171513GA AAD06171521GA AAD06171522GA AAD06221761GA AAD06221780GA AAD06221783GA AAD06231785GA SCS06390095GA SCS06500654GA SCS06500659GA SCS07482033GA SCS08312920GA SCS08312921GA SCS08312922GA SCS08312938GA SCS08493414GA SCS08513453GA SCS08513454GA SCS09073623GA SCS09183734GA SCS09183736GA SCS09193750GA SCS09193751GA SCS09193756GA SCS09193757GA…

Recall started

Oct. 5, 2010

Device type

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

Root cause (FDA)

Software design

What the company told customers

GE Healthcare issued an "Urgent Medical Device Correction" letter dated September 17, 2010 to consignees. The letter was addressed to Hospital Administrator, Head of Biomedical Engineering and Nursing Manager. The letter described the product, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Service representatives will updates all of the affected Transport Pros with PDM that were distributed. Customers may contact GE at 262-548-2731 about this correction.

Recall number

Z-0363-2011

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

Source: FDA · Medical device enforcement report, recall number Z-0363-2011. The agency record governs; check it and the company before acting.