Company: Spacelabs Helathcare Inc. Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs. Recall Number Z-2886-2016 REASON The firm received multiple reports of Xhibit Telemetry System going offline or...Read More

Company: Spacelabs Helathcare Inc. Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Spacelabs Healthcare Xhibit Central Station, Model 96102. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs. Recall Number Z-2885-2016 REASON The firm received multiple reports of Xhibit Telemetry System going offline or locking...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Syngo.plaza, Picture Archiving and Communication System. Recall Number Z-2891-2016 REASON Software upgrade to eliminate several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 9/27/2016 Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 47 systems DISTRIBUTION...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Syngo.plaza VB10A, Picture Archiving and Communication System Recall Number Z-2892-2016 REASON Software upgrade to eliminate several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 9/27/2016 Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 47 systems...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT RTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Recall Number Z-2877-2016 REASON Software patch installation to address several...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Recall Number Z-2876-2016 REASON Software patch installation to address several...Read More

Company: Medtronic Inc. Date of Enforcement Report 10/5/2016 Class lI: PRODUCT CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study...Read More

Company: CareFusion 303 Inc.Date of Enforcement Report 10/52016 Class lI: PRODUCT Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can...Read More