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Terminated

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.

FDA Recall Z-0823-2013 · Posted 2013-02-14

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMHX
Date Initiated2011-09-30
Date Terminated2014-01-27
Product Quantity2813

Reason for Recall

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.

Firm Action

GE Healthcare sent an Important Product Notification letteron September 30, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to keep the patient under close observation or use an alternate monitoring device. Customers should not disconnect the affected USB devices from the patient monitor during an active patient case. If the license is enabled, the alarm limit adjustments from the iCentral Client has an L-NETM-00 license should be disabled. GE Healthcare would contact customers to schedule the update. Customers with questions should contact Technical Support or their local representative. For questions regarding this recall call 262-513-4122.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102239CARESCAPE MONITOR B650GE Healthcare Finland Oy · 2010-10-18

Official Source

View FDA Recall →

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

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