FDAFDA · Food and drugs·Recall number Z-0823-2013
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
Published February 20, 2013 · Recall initiated: September 30, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, FL, GA,IL,IN, IA, KS, KY,LA, MD, MA, MI, M, MO, NE, NE,NJ, NM, NY, NC, OH, OK PA, SC, TN, TX, UT, VA, WI. Internationally to UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, ROMANIA, PORTUGAL, POLAND, PERU, NORWAY, NEW ZEALAND, NETHERLAND, MALAYSIA, LITHUANIA, KUWAIT, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, ICELAND, HONG KONG, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, COLOMBIA, CHILE, CANADA, BELGIUM BAHRAIN, AUSTRIA, AUSTRALIA.
- Lot
- SERIAL NUMBER SEW1181782HA SEW11243524HA SEW11223123HA SEW11223122HA SEW11223121HA SEW11223108HA SEW11223107HA SEW11223106HA SEW11223092HA SEW11223086HA SEW11223085HA SEW11223082HA SEW11223070HA SEW11223022HA SEW11223019HA SEW11223011HA SEW11222999HA SEW11222997HA SEW11202780HA SEW11202778HA SEW11202775HA SEW11202753HA SEW11202750HA SEW11202749HA SEW11202746HA SEW11202745HA SEW11202744HA SEW11202742HA SEW11202741HA SEW11202740HA SEW11202739HA SEW11202737HA SEW11202736HA SEW11202717HA SEW11202716HA SEW11202715HA SEW11202713HA SEW11202712HA SEW11202711HA SEW11202709HA SEW11202708HA SEW11202706HA SEW11202705HA SEW11202704HA SEW11202703HA SEW11202702HA SEW11202700HA SEW11202697HA SEW11202690HA SEW11202687HA SEW11202682HA SEW11202401HA SEW11202400HA SEW11202399HA SEW11202398HA SEW11202397HA SEW11202395HA SEW11202394HA SEW11202390HA SEW11202385HA SEW11202384HA SEW11202383HA SEW11202381HA SEW11202379HA SEW11202378HA SEW11202370HA SEW11202369HA SEW11202368HA SEW11202366HA SEW11202363HA SEW11202362HA SEW11202361HA SEW11202360HA SEW11202359HA SEW11202358HA SEW11202357HA SEW11202353HA SEW11202352HA SEW11202351HA SEW11202348HA SEW11202347HA SEW11202341HA SEW11202340HA SEW11202338HA SEW11202337HA SEW11202336HA SEW11202334HA SEW11202332HA SEW11202331HA SEW11202329HA SEW11202328HA SEW11202325HA SEW11202323HA SEW11202322HA SEW11202320HA SEW11202317HA SEW11202313HA SEW11202310HA SEW11202309HA SEW11202307HA SEW11202301HA SEW11202299HA SEW11202298HA SEW11202296HA SEW11202294HA SEW11202291HA SEW11202290HA SEW11202288HA SEW11202287HA SEW11202286HA SEW11202283HA SEW11202220HA SEW11202203HA SEW11202202HA SEW11181949HA SEW11181947HA SEW11181943HA SEW11181941HA SEW11181936HA SEW11181925HA SEW11181923HA SEW11181920HA SEW11181919HA SEW11181908HA SEW11181895HA SEW11181892HA SEW11181886HA SEW11181882HA SEW11181857HA SEW11181848HA SEW11181828HA SEW11181823HA SEW11181813HA SEW11181797HA SEW11181792HA SEW11181790HA SEW11181788HA SEW11181787HA SEW11181785HA SEW11181782HA SEW11181781HA SEW11181778HA SEW11181776HA SEW11181775HA SEW11181774HA SEW11181773HA SEW11181770HA SEW11181753HA SEW11181752HA SEW11171539HA SEW11171534HA SEW11171532HA SEW11171531HA SEW11171530HA SEW11171527HA SEW11171526HA SEW11171525HA SEW11171511HA SEW11171507HA SEW11171503HA SEW11171499HA SEW11171486HA SEW11171478HA SEW11171472HA SEW11171464HA SEW11171462HA SEW11171456HA SEW11171455HA SEW11171442HA SEW11151285HA SEW11151284HA SEW11151274HA SEW11151269HA SEW11151266HA SEW11151257HA SEW11151255HA SEW11151239HA SEW11151237HA SEW11151236HA SEW11151233HA SEW11151231HA SEW11151219HA SEW11151217HA SEW11151216HA SEW11151215HA SEW11151214HA SEW11151213HA SEW11151211HA SEW11151210HA SEW11151209HA SEW11151208HA SEW11151207HA SEW11151205HA SEW11151204HA SEW11151203HA SEW11151202HA SEW11151200HA SEW11151199HA SEW11151198HA SEW11151197HA SEW11151196HA SEW11151195HA SEW11151194HA SEW11151193HA SEW11151192HA SEW11151191HA SEW11151188HA SEW11141086HA SEW11141081HA SEW11141080HA SEW11141079HA SEW11141078HA SEW11141074HA SEW11141073HA SEW11141072HA SEW11141071HA SEW11141070HA SEW11141065HA SEW11141057HA SEW11141056HA SEW11140873HA SEW11140837HA SEW11130655HA SEW11130652HA SEW11130639HA SEW11130638HA SEW11130632HA SEW11130600HA SEW11130598HA SEW11130594HA SEW11130593HA SEW11130592HA SEW11130591HA SEW11130590HA SEW11120468HA SEW11120467HA SEW11120465HA SEW11120464HA SEW11120443HA SEW11120440HA SEW11120439HA SEW11109999HA SEW11109998HA SEW11109993HA SEW11109991HA SEW11109990HA SEW11109988HA SEW11109987HA SEW11109985HA SEW11109983HA SEW11109982HA SEW11109980HA SEW11109979HA SEW11109978HA SEW11109977HA SEW11109975HA SEW11109974HA SEW11109972HA SEW11109971HA SEW11109970HA SEW11109969HA SEW11109968HA SEW11109966HA SEW11109965HA SEW11109964HA SEW11109963
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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