The latest headlines across every section, pulled from official and open-access sources.
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. — Medtronic Neuromodulation · Class II · Ongoing
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to lo… — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
Nitrile Exam Glove failed to meet specifications chemical permeation performance. — O&M HALYARD INC · Class II · Ongoing
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). — GE Medical Systems Information Technologies Inc · Class II · Ongoing
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to lo… — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. — Devicor Medical Products Inc · Class II · Ongoing
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to… — Abiomed, Inc. · Class I · Ongoing
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). — GE Medical Systems Information Technologies Inc · Class II · Ongoing
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). — GE Medical Systems Information Technologies Inc · Class II · Ongoing
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). — GE Medical Systems Information Technologies Inc · Class II · Ongoing
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. — Medtronic Neuromodulation · Class II · Ongoing
Products were made with recalled California Dairies milk powder due to Salmonella. — Legacy Bakehouse LLC · Class I · Ongoing
Undeclared Milk Allergen, — Wawa Beverage Company · Class I · Ongoing
Undeclared Milk Allergen, — Wawa Beverage Company · Class I · Ongoing
Firm received and used potentially contaminated (Salmonella) ingredient to manufacture various products. — Honeyville, Inc · Class I · Ongoing
Products were made with recalled California Dairies milk powder due to Salmonella. — Legacy Bakehouse LLC · Class I · Ongoing
Products were made with recalled California Dairies milk powder due to Salmonella. — Legacy Bakehouse LLC · Class I · Ongoing
Undeclared Milk Allergen, — Wawa Beverage Company · Class I · Ongoing
Undeclared Milk Allergen, — Wawa Beverage Company · Class I · Ongoing
Possible cross-contamination resulting in undeclared allergen ingredient (Peanut) — Fly By Jing Inc. · Class II · Ongoing
Patients set to benefit from the first sustained expansion of dental school places in nearly 20 years.
Reports on departmental spending over £25,000.
Report bringing together data on the delivery of globally competitive clinical research through the UK Clinical Research Delivery programme.
ECDC and the European Food Safety Authority (EFSA) have today published updated their maps displaying current new knowledge on the spatial distribution of mosquitoes, ticks, sandflies and biting midges across Europe.