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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls

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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. 2 Apr-08-2010 Philips Healthcare Inc.
Z-1260-2010 - DeviceLink Connectivity Hardware. Supports Philips specified manufacturers' devices including urimeters, ventilators, oximeters, patient monitors, infusion pumps and anesthesia machines. 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-1289-2010 - Tidal Wave 610, Refurbished, 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... 2 Apr-08-2010 Philips Healthcare Inc.
Z-1259-2010 - HeartStart MRx- AC power module kit. For use for the termination of ventricular tachycardia and ventricular fibrillation. 2 Apr-08-2010 Philips Healthcare Inc.
Z-1278-2010 - Tidal Wave Sp Model 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 int... 2 Apr-08-2010 Philips Healthcare Inc.
Z-1295-2010 - 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-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-1300-2010 - 100-120V 515B with RS-232 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-1272-2010 - Spanish 100-120V TCOM-860, 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 measurements. 2 Apr-08-2010 Philips Healthcare Inc.
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