Company:Beckman Coulter Inc.. Date of Enforcement Report 11/1/2017 Class lI: PRODUCT Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation. Recall Number Z-0046-2018 REASON Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a retrieval of a sample tube during the rack loading process,...Read More

Company:Nucletron BV Date of Enforcement Report 11/1/2017 Class lI: PRODUCT Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. Recall Number Z-0050-2018 REASON Incorrect...Read More

Company:Edap Technomed Inc. Date of Enforcement Report 11/1/2017 Class lI: PRODUCT Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue Recall Number Z-0049-2018 REASON The US FDA has requested the optional energy treatment settings, “medium” and “low” (Software Protocols 02-Medium and 03-Low) be...Read More