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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-1265-2010 - Evaluation Kit, LOFLO Engine, Respironics/Philips product.
Intended use of the LoFlo C5 CO2 sensor is to provide carbon dioxide 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-1299-2010 - French 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-1271-2010 - French 100-120V 860 TC C02 & 02 Monitor, Respironics/Philips product.
Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measureme...
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1281-2010 - French 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-1258-2010 - HeartStart MRx Defibrillator/Monitor.
For use for the termination of ventricular tachycardia and ventricular fibrillation.
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1259-2010 - HeartStart MRx- AC power module kit.
For use for the termination of ventricular tachycardia and ventricular fibrillation.
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1296-2010 - Japanese 100-120V Oxypleth - 520A 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-1277-2010 - Japanese TidalWave SP 710, 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 i...
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1279-2010 - Japanese TidalWave SP 715, 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 i...
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2
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04/08/2010
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Philips Healthcare Inc.
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Z-1284-2010 - NIC02 Model 7600 Demo Unit, 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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