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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls

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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... 2 Apr-08-2010 Philips Healthcare Inc.
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... 2 Apr-08-2010 Philips Healthcare Inc.
Z-1264-2010 - C5 LOFLO Evaluation Kit, Respironics/Philips product. Intended use of the LoFlo C5 CO2 sensor is to provide carbon dioxide monitoring. 2 Apr-08-2010 Philips Healthcare Inc.
Z-1298-2010 - 515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. 2 Apr-08-2010 Philips Healthcare Inc.
Z-1274-2010 - Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring. 2 Apr-08-2010 Philips Healthcare Inc.
Z-1308-2010 - 100-120V 2001 Pulse Oximeter with Mars, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. 2 Apr-08-2010 Philips Healthcare Inc.
Z-1268-2010 - Cosmo - Model 7100 SP02 & ETC02 Monitor, Respironics./Philips product. Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monitoring en... 2 Apr-08-2010 Philips Healthcare Inc.
Z-1262-2010 - NICO2, Model 7600 Respironics/Philips Product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation. 2 Apr-08-2010 Philips Healthcare Inc.
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. 2 Apr-08-2010 Philips Healthcare Inc.
Z-1285-2010 - NIC02 Model 7600 Refurbished, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during ... 2 Apr-08-2010 Philips Healthcare Inc.
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