GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.
Reported: December 26, 2012 Initiated: February 17, 2012 #Z-0524-2013
Product Description
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.
Reason for Recall
GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 10,250
- Distribution
- Worldwide distribution, including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, LA, KS, KY, LA, ME,MD, MA, MI, MN, MS,MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN,TX, UT,VA, WA, WT, WY and the countries of the UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAK IA, SINGAPORE, SAUDI ARABIA, QATAR, POLAND, PERU, PANAMA, NORWAY, NEW ZEALAND, NETHERLAND, MEXICO, MALAYSIA, LEBANON, KUWAIT, KOREA, JAPAN, ITALY, INDONESIA, INDIA, IRELAND, GERMANY FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COSTA RICA, COLOMBIA, CHILE CANADA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, ARGENTINA, and ALGERIA.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.. Recalled by GE Healthcare, LLC. Units affected: 10,250.
Why was this product recalled? ▼
GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2012. Severity: Moderate. Recall number: Z-0524-2013.
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