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Terminated

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.

FDA Recall Z-1931-2011 · Posted 2011-04-08

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMHX
Date Initiated2011-03-23
Date Terminated2012-02-04
Product Quantity6902

Reason for Recall

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

Firm Action

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.

Root Cause

Software design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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