Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/31/2016 Class lI: PRODUCT SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system. Recall Number Z-2625-2016 REASON Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/31/2016 Class lI: PRODUCT SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system Recall Number Z-2626-2016 REASON Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/31/2016 Class lI: PRODUCT SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system. Recall Number Z-2624-2016 REASON Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT Ingenuity Core128 Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2658-2016 REASON After upgrading to 3.6.7 software version...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT Ingenuity Core Model number 728321 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2657-2016 REASON After upgrading to 3.6.7 software version...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2653-2016 REASON After upgrading to...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2652-2016 REASON After upgrading to 3.6.7 software...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT Brilliance 16, Model number 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2655-2016 REASON After upgrading to 3.6.7 software version...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2656-2016 REASON After upgrading to 3.6.7...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS uses a...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. Recall Number Z-2627-2016 REASON Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the...Read More

Company: INNOKAS MEDICAL OY Date of Enforcement Report 8/31/2016 Class lI: PRODUCT CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient’s vital signs at the site of care. Recall Number Z-2604-2016 REASON A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements. RECALLING FIRM/MANUFACTURER INNOKAS...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2654-2016 REASON After upgrading to 3.6.7...Read More