Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/22/2017 Class lI: PRODUCT 882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/22/2017 Class lI: PRODUCT BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/22/2017 Class lI: PRODUCT BrightView Xdesigned for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings,...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 3/22/2017 Class lI: PRODUCT iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare Recall Number Z-1470-2017 REASON The software produced a number of ”do not route” exceptions, which may result in potential patient injury or delay in diagnosis or treatment.....Read More

FDA seeks manufacturers to provide onsite learning opportunities for FDA staff. In the areas of Digital Health/Software FDA is interested in 4 topics: Cybersecurity, Software Development, Total product life-cycle development processes and methodologies, and Software testing. The link provided is the main FDA webpage on this program and has a link to the full list...Read More

Company: Smiths Medical ASD, Inc. Date of Enforcement Report 3/22/2017 Class lI: PRODUCT CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15, Recall Number Z-1439-2017 REASON I20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 3/22/2017 Class lI: PRODUCT Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data. Recall Number Z-1457-2017 REASON In some instances, the system will lock tabs within a study, even when a second user does not have the study...Read More