🏥 Medical Devices • 15,809 recalls
Windstone Medical Packaging
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Product sterility is compromised due to breach of sterile barrier
Product sterility is compromised due to breach of sterile barrier
Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with Advia Chemistry Enzyme 2 Calibrator lots 6JD079 and 6MD042.
Product sterility is compromised due to breach of sterile barrier
Product sterility is compromised due to breach of sterile barrier
The product was marketed without 510(k) clearance.
Product sterility is compromised due to breach of sterile barrier
eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. A software defect was discovered in the Philips eCareCoordinator (eCC) Clinical User Interface that can at times cause missing or redundant data to be saved without notification to the user.
Product sterility is compromised due to breach of sterile barrier
Problem with colored eluates for whole blood extractions
Product sterility is compromised due to breach of sterile barrier
Resource Optimization & Innovation
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Merge Healthcare
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
Resource Optimization & Innovation
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Resource Optimization & Innovation
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Resource Optimization & Innovation
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Resource Optimization & Innovation
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Resource Optimization & Innovation
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.