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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1282-2010 - Spanish 100-120V NICO 7300, Respironics/Philips product.
Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during ge...
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1275-2010 - Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product.
Used to provide spirometric, carbon dioxide and pulse oximetry monitoring.
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1269-2010 - Spanish 100-120V Cosmo - 7100 Capnograp, Respironics/Philips products.
Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monitoring en...
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1301-2010 - Spanish 100-120V 515B Pulse Oximeter - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1304-2010 - Spanish 100-120V 2001 Pulse Oximeter WI - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1297-2010 - Span 100-120V 520A - OxyPleth Pulse Oximeter - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1263-2010 - Sharn TidalGuard SP 710V, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the in...
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1274-2010 - Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product.
Used to provide spirometric, carbon dioxide and pulse oximetry monitoring.
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1290-2010 - Resp Profile Monitor, 8100 Cosmo+, Refurbished, Respironics/Philips product.
Used to provide spirometric, carbon dioxide and pulse oximetry monitoring during general anesthesia and in the intensive...
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1292-2010 - Refurbished Tidal Wave SP 715, Refurbished, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/r...
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2
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04/08/2010
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Philips Healthcare Inc.
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