PlainRecordsFDA · Medical device recall
GE Healthcare… and 1 more product
- Date posted by the FDA
- April 8, 2011
- Status
- Terminated
- Filed by
- GE Healthcare, LLC
- Reason
- GE Healthcare has become aware of a potential safety issue associated with the CARESCAPE Monitor B650 & B850 Cardiac Output measurement using Patient Data Module (PDM), and activation of ECG Leads Off alarm in specific cases. 1. When the CARESCAPE Monitor is used to measure Cardiac Output values with the Patient Data Module (PDM) or TRAM Module, Cardiac Output values may be calculated incorrectl
- Distribution pattern
- AL, AZ, AR, CA, CO, CT, FL,GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA,PR, SC, TN,TX, UT, VA, WA, WV, WI. UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, SWITZERLAND, SWEDEN SLOVENIA, SLOVAKIA, SPAIN, SINGAPORE, SAUDI ARABIA, QATAR, PORTUGAL POLAND, NORWAY, NORTH KOREA, NEW ZEALAND, NETHERLANDS, MALTA, MALAYSIA, LITHUANIA, LEBANON, KUWAIT, ITALY, ISRAEL, IRELAND, INDIA, ICELAND, HONG KONG, GERMANY, FRANCE, FINLAND, DENMARK, ESTONIA, CZECH REPUBLIC, BELGIUM BAHRAIN, COLOMBIA, CHILE CANADA, BRAZIL, AUSTRIA, AUSTRALIA.
2 products in this recall
GE Healthcare…
- Product
- GE Healthcare, CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital 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. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, EGG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI.
- Quantity
- 1443
- Codes and lots
- Parent SN SEW11059164HA SEW11059150HA SEW11059148HA SEW11059157HA SEW11059167HA SEW11059170HA SEW11059152HA SEW11059176HA SEW11059163HA SEW10393672HA SEW10393682HA SEW10405696HA SEW10467133HA SEW10393675HA SEW10405669HA SEW10405670HA SEW10405673HA SEW10467151HA SEW10467216HA SEW10405542HA SEW11059158HA SEW10517983HA SEW10528081HA SEW10528111HA SEW11018531HA SEW11018538HA SEW11018545HA SEW11018644HA SEW11018645HA SEW11018646HA SEW11018647HA SEW11018650HA SEW11018651HA SEW11018652HA SEW11018653HA SEW11018702HA SEW11018721HA SEW11018725HA SEW11018729HA SEW11018730HA SEW11018731HA SEW11018732HA SEW11038851HA SEW11038918HA SEW11059128HA SEW11059129HA SEW11059130HA SEW11059131HA SEW11059132HA SEW11059133HA SEW11059134HA SEW11059135HA SEW11059136HA SEW11059137HA SEW10385232HA SEW10385234HA SEW10293707HA SEW10293709HA SEW10293712HA SEW10293713HA SEW10293716HA SEW10293717HA SEW10293721HA SEW10293722HA SEW10334184HA SEW10334185HA SEW10334187HA SEW10334190HA SEW10334192HA SEW10334198HA SEW10334204HA SEW10243495HA SEW10243511HA SEW10243515HA SEW10243518HA SEW10243519HA SEW10243521HA SEW10243523HA SEW10243524HA SEW10243525HA SEW10243528HA SEW10243529HA SEW10283653HA SEW10283655HA SEW10334188HA SEW10334193HA SEW10334194HA SEW10467174HA SEW10467182HA SEW10467141HA SEW10467161HA SEW10467163HA SEW10467179HA SEW10467183HA SEW10467185HA SEW10467037HA SEW10467181HA SEW10446466HA SEW10456855HA SEW10467289HA SEW10405667HA SEW10405671HA SEW10405676HA SEW10405685HA SEW10405695HA SEW10405721HA SEW10446478HA SEW10446479HA SEW10467009HA SEW10467010HA SEW10467169HA SEW10293719HA SEW10293720HA SEW10334211HA SEW10334214HA SEW10334219HA SEW10334220HA SEW10334227HA SEW10334233HA SEW10334247HA SEW10334248HA SEW10334277HA SEW10354772HA SEW10354782HA SEW10385222HA SEW10385239HA SEW10385253HA SEW10385254HA SEW10385259HA SEW10385262HA SEW10385272HA SEW10385274HA SEW10467361HA SEW10467380HA SEW10477595HA SEW10467288HA SEW10293714HA SEW10334206HA SEW10334213HA SEW10334226HA SEW10467153HA SEW10467190HA SEW10467208HA SEW10467240HA SEW10467254HA SEW10467255HA SEW10467282HA SEW10467283HA SEW10467287HA SEW10467290HA SEW10467292HA SEW10467207HA SEW10467209HA SEW10467304HA SEW10273635HA SEW10446494HA SEW10456789HA SEW10456794HA SEW10467213HA SEW10467225HA SEW10446496HA SEW10446500HA SEW10456792HA SEW10456795HA SEW10393678HA SEW10393701HA SEW10405663HA SEW10405691HA SEW10405702HA SEW10334251HA SEW10334254HA SEW10507798HA SEW10507814HA SEW10507815HA SEW10477638HA SEW10517980HA SEW11018609HA SEW11018698HA SEW11018700HA SEW11018701HA SEW11018533HA SEW11018539HA SEW11018542HA SEW11018544HA SEW11038919HA SEW11018684HA SEW11018685HA SEW11018686HA SEW11018739HA SEW11018740HA SEW11018741HA SEW11018743HA SEW11059085HA SEW11018543HA SEW10354716HA SEW10354743HA SEW10354689HA SEW10354690HA SEW10354698HA SEW10354699HA SEW10507825HA SEW10507832HA SEW10507834HA SEW10507857HA SEW10507859HA SEW10507861HA SEW10507869HA SEW10405699HA SEW10456800HA SEW10456805HA SEW10507870HA SEW10507871HA SEW10507872HA…
- Recall started
- March 23, 2011
- Device type
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Root cause (FDA)
- Software design
- What the company told customers
- The firm, GE Healthcare, sent "Urgent Medical Device Correction" letters dated March 23, 2011 to its consignees/customers. The letters were addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letters described the Safety Issues, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. The customers were instructed to follow the safety instructions documented in the letter. GE Healthcare is working on a software correction that will be provided to their customers once it is available and will contact the customer to schedule the software update. If you have any questions regarding this medical device correction or the identification of affected items, please contact Technical Support at 1-800-558-7044, or your local Service Representative.
- Recall number
- Z-1930-2011
GE Healthcare…
- Product
- GE Healthcare, CARESCAPE Monitor B850 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital 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. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, EGG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI.
- Quantity
- 6902
- Codes and lots
- Parent SN SED10536360GA SED10536361GA SED10536362GA SED10536363GA SED10536364GA SED10536365GA SED10536368GA SED10536369GA SED10536370GA SED10536371GA SED10536372GA SED10536376GA SED10536377GA SED10536378GA SED10536379GA SED10536380GA SED10536381GA SED10536382GA SED10536383GA SED10536384GA SED10536385GA SED10536386GA SED10536387GA SED10536388GA SED10536389GA SED10536390GA SED10536391GA SED10536392GA SED10515982GA SED11056912GA SED11056923GA SED11056924GA SED11056925GA SED11056926GA SED11056927GA SED11056929GA SED11056930GA SED11056931GA SED11056932GA SED11056933GA SED11056959GA SED11056960GA SED11067132GA SED11067133GA SED11067134GA SED11067135GA SED11067136GA SED11067137GA SED11067139GA SED11067140GA SED11077142GA SED10526112GA SED10526244GA SED10526245GA SED10526253GA SED10526255GA SED10526256GA SED10526263GA SED10526265GA SED10526266GA SED10526293GA SED10526294GA SED10526295GA SED10526296GA SED10526297GA SED10526298GA SED10526301GA SED10526303GA SED10526305GA SED10526307GA SED10526308GA SED10526310GA SED10516098GA SED10526133GA SED10526134GA SED10526142GA SED10526143GA SED11046852GA SEC09440747GA SEC09340300GA SEC09340274GA SEC09340294GA SEC09430557GA SEC09340313GA SED10526115GA SED10536325GA SED10536328GA SED10536330GA SED10536331GA SED10536349GA SED10536350GA SED10536351GA SED10536352GA SED11067056GA SED11067072GA SED11067083GA SEC09430555GA SED10495275GA SED10495309GA SEC09430578GA SEC09340281GA SEC09340279GA SEC09340314GA SED09390860GA.DE; SED10454809GA SED10454812GA SED10454813GA SED10454814GA SED10454815GA SED10515833GA SED10515837GA SED10515838GA SED10515840GA SED10515841GA SED10515842GA SED10515843GA SED10515844GA SED10515845GA SED10515860GA SED10515872GA SED10515878GA SED10515879GA SED10515880GA SED10516089GA SED10526136GA SED10526141GA SED10526146GA SED10536397GA SED10536398GA SED10536413GA SED10536418GA SED10536420GA SED10536424GA SED10536428GA SED10536430GA SED10536432GA SED11057066GA SED11057069GA SED11057070GA SED11097478GA DTK08130668 SEC09340318GA SEC09340306GA SEC09340302GA SEC09430583GA SEC09340336GA SEC09340304GA SEC09340316GA SEC09340277GA SEC09430570GA SED10515834GA SED10515853GA SED10515869GA SED10515886GA SED10515894GA SED10515919GA SEC09430573GA SED10515826GA SED10515998GA SED11036635GA SED11036641GA SED11036669GA SED11036680GA SED11036705GA SED11046709GA SED11046711GA SED11046712GA SED11046713GA SED11046717GA SED11046718GA SED11046719GA SED11046726GA SED11046728GA SED11046733GA SED10404245GA SED10404246GA SED10404249GA SED10404250GA SED10404251GA SED10404252GA SED10404253GA SED10505482GA SED10505500GA SED10505503GA SED10505530GA SED10505531GA SED10505538GA SED10505539GA SED10505551GA SED10505554GA SED10505561GA SED10505569GA SED10505601GA SED11046737GA SEC09340335GA SEC09340312GA SEC09340320GA SED11067074GA SED11097452GA SEC09340310GA SED10464941GA SEC09340341GA SEC09340338GA SEC09340308GA SEC09340337GA SEC09420529GA SEC09430562GA SEC09430577GA SEC09430575GA SEC09420524GA SEC09430619GA SEC09420534GA SED11056963GA…
- Recall started
- March 23, 2011
- Device type
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Root cause (FDA)
- Software design
- What the company told customers
- The firm, GE Healthcare, sent "Urgent Medical Device Correction" letters dated March 23, 2011 to its consignees/customers. The letters were addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letters described the Safety Issues, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. The customers were instructed to follow the safety instructions documented in the letter. GE Healthcare is working on a software correction that will be provided to their customers once it is available and will contact the customer to schedule the software update. If you have any questions regarding this medical device correction or the identification of affected items, please contact Technical Support at 1-800-558-7044, or your local Service Representative.
- Recall number
- Z-1931-2011
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1930-2011, Z-1931-2011. The agency record governs; check it and the company before acting.