Company: Toshiba American Medical Systems Inc. Date of Enforcement Report 2/17/2016 Class lI: PRODUCT INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems Recall Number Z-0752-2016 REASON When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value...Read More

Company: Merge Healthcare Inc. Date of Enforcement Report 2/10/2016 Class lI: PRODUCT RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7...Read More