Company:Cepheid. Date of Enforcement Report 6/8/2011 Class ll: PRODUCT Xpert Infinity Software, V 4.1a. System software for GeneXpert Infinity 48. Recall # Z-2401-2011 REASON A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are...Read More

Company: Computerized Medical Systems Inc. Date of Enforcement Report 6/8/2011 Class ll: PRODUCT XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2408-2011 REASON XiO Software is not transferring the correct information...Read More

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Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 6/8/2011 Class ll: PRODUCT ACUSON S2000 ultrasound system. Intended for the following applications: Fetal, abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular Applications. Model Number 10041461-ACUSON S2000. Recall # Z-2051-2011 REASON The Firm discovered a software...Read More