FDAFDA · Alimentos y medicamentos·N.º oficial Z-0648-2014
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
Publicado el 15 de enero de 2014 · Inicio del retiro: 16 de diciembre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June 2010, encompassing Fiscal Week 13, 2007 through 26, 2010 due to fluid ingress into the top cover assembly which can result in heat buildup.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, O, NE, NV,NH, NJ, NM, NY, NC, OH, OK, OR,PA PR, RI,SC, TN, TX, UT, VT, VA, WA, WI, and WY. Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LEBANON,LITHUANIA, MALAYSIA, MAURITIUS, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, QATAR , SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
- Lote
- Mfg Lot or Serial # SA307140598GA SA307140599GA SA307140600GA SA307140601GA SA307140605GA SA307140606GA SA307140607GA SA307140610GA SA307140611GA SA307140612GA SA307140614GA SA307140615GA SA307140618GA SA307140619GA SA307140622GA SA307140623GA SA307140627GA SA307140628GA SA307140631GA SA307140632GA SA307140636GA SA307140637GA SA307140639GA SA307140640GA SA307140641GA SA307140642GA SA307140644GA SA307150645GA SA307150646GA SA307150655GA SA307150656GA SA307020391GA SA307030405GA SA307030424GA SA307070446GA SA307070447GA SA307070448GA SA307080462GA SA307080463GA SA307080484GA SA307080508GA SA307080523GA SA307110548GA SA307110556GA SA307110571GA SA307190716GA SA307190737GA SA307190739GA SA307190750GA SA307190768GA SA307020379GA SA307020384GA SA307020386GA SA307030407GA SA307030409GA SA307030412GA SA307030414GA SA307060432GA SA307070436GA SA307070440GA SA307070441GA SA307070442GA SA307070450GA SA307070453GA SA307070454GA SA307070455GA SA307080472GA SA307080477GA SA307080478GA SA307080504GA SA307080520GA SA307080526GA SA307110559GA SA307110560GA SA307110572GA SA307110575GA SA307110579GA SA307120587GA SA307120588GA SA307150681GA SA307180694GA SA307180696GA SA307180697GA SA307190717GA SA307190718GA SA307190720GA SA307190722GA SA307190724GA SA307190727GA SA307190728GA SA307190729GA SA307190730GA SA307190732GA SA307190733GA SA307190734GA SA307190738GA SA307190741GA SA307190742GA SA307190743GA SA307190744GA SA307190745GA SA307190749GA SA307190764GA SA307190766GA SA307190769GA SA307190770GA SA307190771GA SA307020383GA SA307030411GA SA307030413GA SA307050429GA SA307070443GA SA307080459GA SA307080467GA SA307080521GA SA307080522GA SA307080524GA SA307150651GA SA307180699GA SA307190736GA SA307190755GA SA307190773GA SA307190774GA SA307200784GA SA307220983GA SA307221081GA SA307221089GA SA307020393GA SA307020396GA SA307020397GA SA307020399GA SA307030417GA SA307030419GA SA307030423GA SA307070438GA SA307080473GA SA307080493GA SA307080498GA SA307080499GA SA307080509GA SA307080510GA SA307080533GA SA307150671GA SA307180698GA SA307180701GA SA307180702GA SA307180704GA SA307180705GA SA307180706GA SA307190731GA SA307190751GA SA307190752GA SA307190754GA SA307190756GA SA307190757GA SA307190772GA SA307200776GA SA307200777GA SA307210815GA SA307210819GA SA307210863GA SA307220869GA SA307220870GA SA307220872GA SA307220875GA SA307220877GA SA307220878GA SA307220879GA SA307220880GA SA307220888GA SA307220890GA SA307220892GA SA307220893GA SA307220898GA SA307220900GA SA307220902GA SA307220903GA SA307220904GA SA307220923GA SA307220931GA SA307220932GA SA307220963GA SA307220986GA SA307220999GA SA307221016GA SA307221026GA SA307221027GA SA307221028GA SA307221092GA SA307221084GA SA307221109GA SA307221179GA SA307231201GA SA307231375GA SA307231402GA SA307231416GA SA307231475GA SA307080502GA SA307231199GA SA307231208GA SA307231374GA SA307080466GA SA307080469GA SA307080488GA SA307080489GA SA307080491GA SA307080497GA SA307140621GA SA307180707GA SA307180708GA SA307190753GA SA307190759GA SA307190760GA SA307190761GA SA307190762GA SA307200792GA SA307200793GA SA307200794GA SA307200795GA SA307200796GA SA307200797GA SA307200798GA SA307200799GA SA307200801GA SA307200802GA SA307200803GA SA307200804GA SA307210829GA SA307210835GA SA307220936GA SA307220945GA SA307221000GA SA307221001GA SA307221003GA SA307221009GA SA307221043GA SA307221045GA SA307221047GA SA307221061GA SA307221064GA SA307221070GA SA307231264GA SA307231351GA SA307220949GA SA307210832GA SA307210833GA SA307210838GA SA307210843GA SA307220938GA SA307220942GA SA307220954GA SA307220955GA SA307220959GA SA307221039GA SA307221040GA SA307221041GA SA307221048GA SA307221056GA SA307221059GA SA307221068GA SA307220908GA SA307221100GA SA307221101GA SA307221110GA SA307221113GA SA30
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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