|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
Z-1257-2010 - AC power cords manufactured by Electri-Cord with tall bridge design. Used across all Philips product lines, as well as Respironics/Philips products, Dixtel owned products and Dixtal (formerly Novamet...
|
2
|
04/08/2010
|
Philips Healthcare Inc.
|
Z-1309-2010 - 100-120V 2001 Pulse Oximeter with Mars Nurse Call, Refurbished - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate....
|
2
|
04/08/2010
|
Philips Healthcare Inc.
|
Z-1259-2010 - HeartStart MRx- AC power module kit.
For use for the termination of ventricular tachycardia and ventricular fibrillation.
|
2
|
04/08/2010
|
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
|
04/08/2010
|
Philips Healthcare Inc.
|
Z-1261-2010 - Evaluation Kit, Capnostat 5, Respironics/Philips Product.
Intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system.
|
2
|
04/08/2010
|
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
|
04/08/2010
|
Philips Healthcare Inc.
|
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...
|
2
|
04/08/2010
|
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
|
04/08/2010
|
Philips Healthcare Inc.
|
Z-1265-2010 - Evaluation Kit, LOFLO Engine, Respironics/Philips product.
Intended use of the LoFlo C5 CO2 sensor is to provide carbon dioxide monitoring.
|
2
|
04/08/2010
|
Philips Healthcare Inc.
|
Z-1266-2010 - 100-120V Capnogard 1265, Respironics/Philips product.
Intended to be used for monitoring end tidal CO2 and respiration rate in all critical monitoring environments.
|
2
|
04/08/2010
|
Philips Healthcare Inc.
|