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.
Reported: February 20, 2013 Initiated: September 30, 2011 #Z-0823-2013
Product Description
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.
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 2813
- Distribution
- 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.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by GE Healthcare, LLC. Units affected: 2813.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 20, 2013. Severity: Moderate. Recall number: Z-0823-2013.
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