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GE Healthcare, LLC recalls GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acqui
Recalled January 22, 2014 · FDA recall Z-0747-2014 · GE Healthcare
Hazard
GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012. · FDA Class II
Units
43,033 (25,681 USA; 17,352 OUS)
Sold at
Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN, MS, NO, NE, NV, NJ, NM, NY, NC, OH, OK,OR, PA, RI, SC, TN, TX, UT,VT, VA, WA, WI, and WY. Internationally to: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Egypt,England, Estonia, Finland,France, Germany,Greece, Guatemala, Hungary,India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Mauritius, Mexico, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates and United Kingdom.
Description
GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012.
Product
GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →