Company:St Jude Medical CRMD. Date of Enforcement Report 7/13/2011 Class ll: PRODUCT SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia. Recall # Z-2733-2011 REASON The recall was...Read More

Company:Computerized Medical Systems Inc. Date of Enforcement Report 7/13/2011 Class ll: PRODUCT Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall # Z-2561-2011. REASON Monaco: For VMAT...Read More