Company: Hologic, Inc. Date of Enforcement Report: 12/27/2018 Class II PRODUCT I-View Contrast Enhanced Digital Mammography, ASY-08109 Recall Number: Z-0685-2019 REASON Calibration issue not possible to visualize contrast uptake in the subtracted mammography images RECALLING FIRM/MANUFACTURER Hologic, Inc., Danbury, CT on 12/6/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 337 units...Read More

Company: Elekta, Inc. Date of Enforcement Report: 12/27/2018 Class II PRODUCT MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery Recall Number: Z-0686-2019 REASON If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup...Read More

Company: Radiometer America Inc Date of Enforcement Report: 12/22/2018 Class II PRODUCT ABL800 analyzer, model numbers 393-800 and 393-801. Recall Number: Z-0682-2019 REASON The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur. RECALLING FIRM/MANUFACTURER Radiometer America Inc, Brea, CA on 7/3/2018. Voluntary: Firm Initiated...Read More

Company: Medtronic Inc. Date of Enforcement Report: 12/22/2018 Class II   PRODUCT Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International) Recall Number: Z-0683-2019   REASON Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or...Read More