Company: Linvatec Corp. dba ConMed Linvatec Date of Enforcement Report: 5/29/2013 Class ll: PRODUCT Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures. Recall Number Z-1340-2013 REASON The VP1600 HD Still Capture Image System is recalled due to an anomaly...Read More

Company: Medical Information Technology, Inc.Date of Enforcement Report: 5/29/2013 Class ll: PRODUCT MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH’s Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information. Recall Number Z-1365-2013 REASON Incorrect transmission of laboratory results. RECALLING FIRM/MANUFACTURER Medical Information Technology, Inc., Westwood,...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 5/29/2013 Class ll: PRODUCT Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Philips...Read More