Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/7/12 Class ll: PRODUCT Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image processing system. Model number 10592457. Recall # Z-1127-2012 REASON There is a potential malfunction when using syngo.plaza VA20B_HF04 with USB dongle and archive license. In syngo.plaza VA20B_HF04, there is a scenario where...Read More

Company:Philips Medical Systems Nederlands. Date of Enforcement Report 3/7/12 Class ll: PRODUCT Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model: 881001. Indicated for use as a diagnostic device. Recall # Z-1125-2012 REASON There maybe incorrect values in the diffusion/perfusion maps. RECALLING FIRM/MANUFACTURER Philips Medical Systems Nederlands, Best, Netherlands, by...Read More

Company:Mindray DS USA, Inc. d.b.a. Mindray North America Date of Enforcement Report 3/7/12 Class ll: PRODUCT V Series Monitor. The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment Analysis...Read More