Company: Respironics California, Inc.Date of Enforcement Report:1/18/2006 Class:lI PRODUCT The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is...Read More

Company: Philips Medical Systems North America Co.Date of Enforcement Report:1/18/2006 Class:lI PRODUCT Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging. Recall # Z-0358-06 REASON The Gyroscan NT MRI system has a computer software problem which results in images from one patient being placed into another patient’s image record.....Read More