April 11, 2018
Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/11/2018 Class lI: PRODUCT Syngo.via. Medical Device Software. Picture archiving and communications system Recall Number Z-1303-2018 REASON A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving...
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Company:Baxter Healthcare CorporationDate of Enforcement Report 4/11/2018 Class lI: PRODUCT Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system.Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. Recall Number Z-1280-2018 REASON Firm has received reports of device operators failing to adhere to...
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Company:Phadia Ab.Date of Enforcement Report 4/11/2018 Class lI: PRODUCT Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4. Recall Number Z-1276-2018 REASON We want to inform...
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Company:GE HealthcareDate of Enforcement Report 4/11/2018 Class lI: PRODUCT GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or...
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Company:Fresenius Medical Care Renal Therapies Group, LLCDate of Enforcement Report 4/11/2018 Class lI: PRODUCT 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy. Recall Number Z-1278-2018 REASON...
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Company:Invivo Corporation.Date of Enforcement Report 4/11/2018 Class lI: PRODUCT DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed...
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