FDA-Device2014-01-15Class II
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
GE Healthcare, LLC
Hazard
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.
Sold states
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.
Affected count
17,444 (11,418 units US, 6,026 units OUS).
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0648-2014Don't want to check this manually?
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