Company: GE Healthcare, LLC Date of Enforcement Report: 6/19/2019 Class II PRODUCT GE Centricity PACS-IW versions 3.6.0 through 220.127.116.11 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x Recall Number: Z-1781-2019 REASON There is a potential that one or more image series (i.e., all images within an image...Read More
Company: Philips North America, LLC Date of Enforcement Report: 6/19/2019 Class III PRODUCT Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the...Read More
Company: Terumo Cardiovascular Systems Corporation Date of Enforcement Report: 6/19/2019 Class II PRODUCT Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass. Recall Number: Z-1769-2019 REASON An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration...Read More
Company: Conformis, Inc. Date of Enforcement Report: 6/19/2019 Class II PRODUCT Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT) Recall Number: Z-1775-2019 Recall Number: Z-1776-2019 REASON Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants. RECALLING...Read More
Company: Medtronic Neuromodulation Date of Enforcement Report: 6/19/2019 Class II PRODUCT InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim...Read More
Company: One Lambda Inc Date of Enforcement Report: 6/19/2019 Class II PRODUCT UniMatch Plus Software (Catalog ID 790111 and A10286, Version 6.0) when used in association with CHR_005_201807v1.uch Recall Number: B-0675-2019 REASON The UniMatch Plus Software, containing incorrect allele specificity information, which may result in an ambiguous result or a mistyping, was distributed. RECALLING FIRM/MANUFACTURER...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.