Company:Sunquest Information Systems, Inc. Date of Enforcement Report 11/14/12 Class ll: PRODUCT Sunquest Laboratory, version 7.0 not available. Recall Number Z-0250-2013 REASON Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data. RECALLING FIRM/MANUFACTURER Sunquest Information...Read More

Company:Sunquest Information Systems, Inc. Date of Enforcement Report 11/14/12 Class ll: PRODUCT Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later. Recall Number Z-0251-2013 REASON The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately. RECALLING FIRM/MANUFACTURER...Read More

Company:Philips Medical Systems Date of Enforcement Report 11/14/12 Class ll: PRODUCT Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3...Read More

Company:Sendx Medical Inc Date of Enforcement Report 11/14/12 Class ll: PRODUCT ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained...Read More

Company:Sechrist Industries Inc Date of Enforcement Report 11/14/12 Class ll: PRODUCT Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures. Recall Number Z-0208-2013 and Z-0209-2013 REASON Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with...Read More