Company:ORTHO-CLINICAL DIAGNOSTICSDate of Enforcement Report 4/192017 Class lI: PRODUCT VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD — Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK Recall Number Z-1765-2017 REASON Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these...Read More

Company:Roche Diagnostics CorporationDate of Enforcement Report 4/192017 Class lI: PRODUCT Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx Recall Number Z-1764-2017 REASON “Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (URF) modules with software version 02-xx, only when...Read More

Company:Roche Diagnostics CorporationDate of Enforcement Report 4/192017 Class lI: PRODUCT Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Recall Number Z-1763-2017 REASON “Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (URF) modules with software version 02-xx, only when...Read More

Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report 4/19/2017 Class lI: PRODUCT Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used...Read More

Company:PerkinElmer Life and Analytical Sciences, Wallac, OYDate of Enforcement Report 4/192017 Class lI: PRODUCT Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Recall Number Z-1761-2017 REASON “Roche Diagnostics Corp. initiated a voluntary correction because a...Read More

Company:Nihon Kohden America, IncDate of Enforcement Report 4/192017 Class lI: PRODUCT Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA). Recall Number Z-1768-2017 REASON The Pause function on central monitors will not automatically resume when connected to a Life Scope G9...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 4/19/2017 Class lI: PRODUCT Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure Recall Number Z-1778-2017 REASON Use of the software may show an incorrect...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 4/19/2017 Class lI: PRODUCT iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Recall Number Z-1762-2017 REASON Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording. RECALLING...Read More

Company:GE Healthcare, LLCDate of Enforcement Report 4/192017 Class lI: PRODUCT 1. Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA. Recall Number Z-1779-2017 2. Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD. Recall Number Z-1779-2017 REASON GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where...Read More

Company: Draegar Medical Systems, Inc. Date of Enforcement Report 4/19/2017 Class lI: PRODUCT Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Recall Number Z-1773-2017 REASON It was reported that a set low O2 alarm does not go off although the measured O2...Read More

Company: Draegar Medical Systems, Inc. Date of Enforcement Report 4/19/2017 Class lI: PRODUCT Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Recall Number Z-1772-2017 REASON It was reported that a set low O2 alarm does not go off although the measured O2 level...Read More