Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Syngo.plaza systems with SW VB20A, Model Number – 10863171, 10863172, 10863173Product Usage:Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning....Read More

Company:Spacelabs Healthcare Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, Recall Number Z-0532-2018 REASON Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring. RECALLING FIRM/MANUFACTURER Spacelabs Healthcare Inc., Snoqualmie, WA on 1/17/2018. Voluntary: Firm...Read More

Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Philips Ingenuity CT computed tomography x-ray system Recall Number Z-0521-2018 REASON Numerous issues related to software Brilliance iCT 4.1.6 software version. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 10/6/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Philips Ingenuity Core computed tomography x-ray system Recall Number Z-0519-2018 REASON Numerous issues related to software Brilliance iCT 4.1.6 software version. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 10/6/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Philips Ingenuity Core 128 computed tomography x-ray system Recall Number Z-0520-2018 REASON Numerous issues related to software Brilliance iCT 4.1.6 software version. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 10/6/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT...Read More

Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Philips Brilliance 64 computed tomography x-ray system Recall Number Z-0518-2018 REASON Numerous issues related to software Brilliance iCT 4.1.6 software version. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 10/6/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More