FDA-Device2014-11-05Class I
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
Hospira Inc.
Hazard
The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.
Sold states
Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the countries of Austria, Belgium, Brazil, Columbia, France, Germany, Greece, Netherlands, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Affected count
978 power supplies
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0095-2015Don't want to check this manually?
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