Company:Natus Neurology Inc.Date of Enforcement Report: 11/4/2015 Class lI: PRODUCT ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 11/4/2015 Class lI: PRODUCT CIOS ALPHA; image intensified fluoroscopic x-ray system Recall Number Z-0118-20166 REASON patient procedure interruption due to a potential system failure RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 8/7/2015 Voluntary: Firm Initiated recall is ongoing VOLUME OF PRODUCT IN COMMERCE 44...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 11/4/2015 Class lI: PRODUCT ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.Recall Number Z-0182-2016 REASON Siemens will provide all customers a new version of system software (VA35E or VB10C...Read More

Company: Perkin Elmer Life Sciences Inc. Date of Enforcement Report 11/4/2015 Class lI: PRODUCT Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.Recall Number Z-0166-2016 REASON It would be possible for an abnormal analytical test result value from an affected newborn...Read More

Company:Elekta Inc.Date of Enforcement Report: 11/4/2015 Class lI: PRODUCT Monaco – Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-0181-2016 REASON Unintended update of Dose and MU and Incorrect Assignment of Bolus. RECALLING FIRM/MANUFACTURER Elekta Inc., Atlanta, GA on 10/16/2015 Voluntary: Firm Initiated recall...Read More