Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 12/15/11 Class ll: PRODUCT 1) Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical...Read More

Company:Steris Corp Date of Enforcement Report 12/15/11 Class ll: PRODUCT SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3. Recall #Z-0278-2012. REASON Potential for patient data to be sent to the wrong patient record. A software...Read More

Company:Elekta, Inc. Date of Enforcement Report 12/15/11 Class ll: PRODUCT Elekta Synergy XVI R.4.5 and R4.6 Product Usage: To be used as part of radiation therapy treatment process. Recall # Z-0320-2012 REASON The software did not operate as expected. RECALLING FIRM/MANUFACTURER Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated October 14, 2011. Manufacturer: Elekta...Read More