Day

May 29, 2019
Company: Neusoft Medical Systems Co., Ltd. Date of Enforcement Report: 5/29/2019 Class II PRODUCT NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by...
Read More
Company: KaVo Dental Technologies LLC Date of Enforcement Report: 5/29/2019 Class II PRODUCT DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform...
Read More
Company: Elekta Instrument AB Date of Enforcement Report: 5/29/2019 Class II PRODUCT Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning. Recall Number: Z-1412-2019 REASON The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume. RECALLING FIRM/MANUFACTURER Elekta Instrument AB...
Read More
Company: Roche Diagnostics Corporation Date of Enforcement Report: 5/29/2019 Class II PRODUCT Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use Recall Number: Z-1368-2019 REASON Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to...
Read More

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.