Company: Biolase Technology IncDate of Enforcement Report: 8/27/2014 Class lI: PRODUCT WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463. Recall Number Z-2263-2014 REASON Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7). If an error occurs in...Read More

Company: Invivo CorporationDate of Enforcement Report: 8/27/2014 Class lI: PRODUCT Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures. Recall Number Z-2270-2014 REASON...Read More

Company: Philips Healthcare Informatics, Inc. Date of Enforcement Report 8/27/2014 Class lI: PRODUCT Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage. Recall Number Z-2252-2014 REASON A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/27/2014 Class lI: PRODUCT Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426 Recall Number Z-2535-2014 REASON Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress...Read More

Company:Intelerad Medical SystemsDate of Enforcement Report: 8/27/2014 Class lI: PRODUCT IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging...Read More

Company: Nellcor Puritan Bennett Inc. (dba Covidien LP)Date of Enforcement Report: 8/27/2014 Class lI: PRODUCT Vital Sync” VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be...Read More

Company: Brainlab AG.Date of Enforcement Report: 8/27/2014 Class lI: PRODUCT Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient’s preoperative or Intraoperative...Read More

Company: Ansar Group, Inc.Date of Enforcement Report: 8/27/2014 Class lI: PRODUCT blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of a number of components. The components are the following: 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory...Read More