Fujifilm Medical Systems U.S.A., Inc. - Class 2 Recall
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2021 Category: Medical Devices Source Type: alerts
ROi CPS LLC - Regard custom cardiovascular procedural pack - Class 2 Recall
Regard, Item Number 830067009, custom cardiovascular procedure kit (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2021 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Herc Flex Universal Stabilizer Arms - Class 2 Recall
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 7, 2021 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge - Class 2 Recall
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 9, 2021 Category: Medical Devices Source Type: alerts
Philips Ultrasound Inc - Philips EPIQ Diagnostic Ultrasound System - Class 2 Recall
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 4, 2021 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - HLS Set Advanced - Class 2 Recall
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 18, 2020 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - HLS Set Advanced - Class 2 Recall
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 18, 2020 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Capiox FX25 Advance Oxygenator - Class 2 Recall
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25REC CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 15, 2020 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - Blood Monitoring Unit (BMU 40) - Class 2 Recall
Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct). (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 13, 2020 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - Yuno Mobile Operating Table - Class 2 Recall
Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS) (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - Yuno II Mobile Operating Table - Class 2 Recall
Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143302F0 (US) Part 143302B0 (OUS) (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts
Riverpoint Medical, LLC - Velosorb Fast Braided Absorbable Suture - Class 2 Recall
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2020 Category: Medical Devices Source Type: alerts
Riverpoint Medical, LLC - Velosorb Fast Braided Absorbable Suture - Class 2 Recall
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" SC-1, Product Number: SV2239, UDI: 20884521151779 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2020 Category: Medical Devices Source Type: alerts
Riverpoint Medical, LLC - Velosorb Fast Braided Absorbable Suture - Class 2 Recall
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2020 Category: Medical Devices Source Type: alerts
Riverpoint Medical, LLC - Velosorb Fast Braided Absorbable Suture - Class 2 Recall
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" CV-23 Taper, Product Number: CV1213, UDI: 20884521150758 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2020 Category: Medical Devices Source Type: alerts
