Company: ViewRay Inc.Date of Enforcement Report: 5/13/2015 Class lI: PRODUCT ViewRay System, Radiation Therapy System Recall Number Z-1580-2015 REASON The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error. RECALLING FIRM/MANUFACTURER ViewRay Inc, Oakwood Village,...Read More
Company:Stryker Instruments Div. of Stryker Corporation.Date of Enforcement Report: 5/13/2015 Class lII: PRODUCT Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece...Read More
Company: Spacelabs Healthcare IncDate of Enforcement Report: 5/13/2015 Class lI: PRODUCT Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any...Read More
Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 5/13/2015 Class lI: PRODUCT ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative...Read More
Company: MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK.Date of Enforcement Report: 5/13/2015 Class lI: PRODUCT MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) Recall Number Z-1574-2015 REASON The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment...Read More
FDA issued a Medwatch alert for infusion pumps May 13, 2015, regarding security vulnerabilities in Hospira’s LifeCare PCA3 and PCA5 Infusion Pump Systems. A researcher has shown that exploiting the vulnerabilities could allow an unauthorized user to remotely modify the dosage delivered. Homeland security was previously working with Hospira about this vulnerability (we reported on...Read More
Company: Eos Imaging Inc.Date of Enforcement Report: 5/13/2015 Class lI: PRODUCT EOS, Digital radiography system used in general radiographic examinations. Recall Number Z-1460-2015 REASON When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with...Read More
Company:Brainlab AGDate of Enforcement Report: 5/13/2015 Class lI: PRODUCT ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. Recall Number Z-1582-2015 REASON ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam...Read More
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