216 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3.
FDA Recall
Terminated
·SCC Soft Computer·Product code LNX·March 22, 2011
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
FDA Recall
Terminated
·Med-Hot Thermal Imaging, Inc.·Product code LHQ·January 14, 2017
CURAD REUSABLE GEL HOT/COLD PACK
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code IME·December 15, 2021
Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.
FDA Recall
Terminated
·Soft Computer Consultants, Inc.·Product code NSX·October 6, 2016
SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.
FDA Recall
Terminated
·Soft Computer Consultants, Inc.·Product code NSX·October 6, 2016
Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code IME·September 28, 2022
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 20, 2024
SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable, trained, and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of viewing and printing data stored in SCC product databases.
FDA Recall
Terminated
·SCC Soft Computer·Product code LNX·October 25, 2011
AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
FDA Recall
Open, Classified
·ZOLL Circulation, Inc.·Product code DRM·September 22, 2022
THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
FDA Recall
Terminated
·Lansinoh Laboratories Inc·Product code IME·August 14, 2012
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 19, 2025
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 19, 2025
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 19, 2025
Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code IME·September 28, 2022
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.
FDA Recall
Terminated
·Soft Computer Consultants, Inc.·Product code JQP·March 31, 2021