May 14, 2014
Company: Shimadzu Medical Systems Date of Enforcement Report:5/14/2014 Class lI: PRODUCT Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices. Recall Number Z-1569-2014 REASON Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a...
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Company: INO Therapeutics Date of Enforcement Report:5/14/2014 Class lI: PRODUCT INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting...
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Company: GE Healthcare Date of Enforcement Report:5/14/2014 Class lI: PRODUCT Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with...
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