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Found 30 result(s) for "Signal Management".

Showing 1-20 of 30 published article match(es)

publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 8, 2026

Field Safety Notice: Bolton Medical RelayPro Thoracic Stent-Graft System (NBS)

Urgency: High

Verify inventory of affected RelayPro Thoracic Stent-Graft System lots (model 28-N4-XX-XXX-XXS) and implement actions per the FSN document.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Field Safety Notice (FSN)
Read impact briefarrow_forward
publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 8, 2026

Class 4 Defect Notification: Cadila Mirtazapine 30mg Tablets (EL(26)A/28)

Urgency: High

Check for affected batches of Mirtazapine 30mg Tablets as described in EL(26)A/28 and implement any necessary quarantining or recall steps.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medicines Defect Notification (Class 4)
Read impact briefarrow_forward
publicFDA · USA · Updated Jun 5, 2026

GE HealthCare Infant Resuscitation System Air-Oxygen Blender Issue

Urgency: High

Identify and remove affected devices from use until corrected; if use is necessary, follow additional precautions provided in the GE HealthCare customer letter.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Early Alert
Read impact briefarrow_forward
publicSwissmedic · Switzerland · Updated Jun 5, 2026

Urgent Field Safety Notice (RECALL) - One-Piece Guedel Airways

Urgency: High

Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Field Safety Notice / Recall
Read impact briefarrow_forward
publicFDA · USA · Updated Jun 5, 2026

GE HealthCare Carestation Devices - Correction for Ineffective Ventilation in VCV Mode (FDA Class I Recall)

Urgency: High

Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medical Device Recall / Correction
Read impact briefarrow_forward
publicEuropean Medicines Agency (EMA) · European Union · Updated Jun 5, 2026

EMA Updates Acceptable Intake Levels for Nitrosamine Impurities in Human Medicines

Urgency: High

Manufacturers must verify that their products meet the newly established acceptable intake levels for nitrosamines and implement necessary quality control measures to keep impurities within limits.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Regulatory Update
Read impact briefarrow_forward
publicHealth Canada · Canada · Updated Jun 5, 2026

Cosyland Kids Kitchen Step Stools recalled due to fall and entrapment hazards (Model CS0003)

Urgency: High

Immediately stop using the recalled stools, store away from children, and contact Wan Yi (866-677-3889 / customerservice-ca@cosyland.com) to request free repair parts (protective nets, stabilizing feet, instructions).

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Consumer product recall
Read impact briefarrow_forward
publicEuropean Medicines Agency (EMA) · European Union · Updated Jun 5, 2026

Ixchiq (Chikungunya vaccine (live)) - Safety measures following PRAC review

Urgency: High

Update product information and guidance for use in elderly populations for Ixchiq; ensure compliance with PRAC recommendations.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: PRAC recommendation
Read impact briefarrow_forward
publicTGA · Australia · Updated Jun 5, 2026

TGA Safety Alert: FluMist Indicated Age Range Errors

Urgency: High

Confirm child is 24 months or older before administering FluMist; review Product Information; verify patient age against indication.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Alert
Read impact briefarrow_forward
publicHealth Canada · Canada · Updated Jun 4, 2026

Wyze Solar Cam Pan Recalled Due to Burn and Fire Hazards

Urgency: High

Immediately stop use; visit Wyze Labs website for refund process. Report incidents to Health Canada.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Consumer product recall
Read impact briefarrow_forward
publicTherapeutic Goods Administration (TGA) · Australia · Updated Jun 4, 2026

Recall: Nature's Own Glucosamine Sulfate with Chondroitin and Magnesium Glycinate 1150mg

Urgency: High

Stop using affected batches; return to place of purchase for full refund.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Recall
Read impact briefarrow_forward
publicTherapeutic Goods Administration (TGA) · Australia · Updated Jun 4, 2026

Pharmatech MK-677 Capsules: Undisclosed Anabolic Steroid Found

Urgency: High

Stop using and dispose of Pharmatech MK-677 capsules immediately; consult a healthcare professional if concerned.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Alert
Read impact briefarrow_forward
publicHSA · Singapore · Updated Jun 4, 2026

Urgent Field Action Notification of Advanced Bionics HiRes Ultra / Ultra 3D

Urgency: High

Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Urgent Field Action
Read impact briefarrow_forward
publicHealth Canada · Canada · Updated Jun 4, 2026

ARTIS Icono Ceiling, Floor and Biplane Systems Recall

Urgency: High

Identify and quarantine affected ARTIS Icono systems in inventory; contact manufacturer for update guidance.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Health Product Recall
Read impact briefarrow_forward
publicHealth Canada · Canada · Updated Jun 4, 2026

Giraffe™ OmniBed™ Carestation™ - Fastener Disengagement Risk

Urgency: High

Healthcare facilities should implement manufacturer's corrective actions to ensure safe operation.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medical Device Recall
Read impact briefarrow_forward
publicHSA · Singapore · Updated Jun 4, 2026

HeartWare Ventricular Assist System Batteries - HSA Field Safety Notice

Urgency: High

Identify and quarantine affected HeartWare batteries; follow manufacturer's instructions for battery management and replacement; ensure patients and healthcare providers are informed.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Field Safety Notice
Read impact briefarrow_forward
publicFDA · USA · Updated Jun 4, 2026

FDA Safety Labeling Change Order for ADZYNMA

Urgency: High

Review the specific labeling changes required by the FDA order and update internal safety documents and signal evaluation for ADZYNMA accordingly.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Labeling Change Order
Read impact briefarrow_forward
publicTGA · Australia · Updated Jun 4, 2026

Unapproved ibutamoren capsules (MK-677) found to contain undisclosed anabolic steroid

Urgency: High

Consumers must stop taking the product immediately and return remaining capsules to a pharmacy for safe disposal.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Alert
Read impact briefarrow_forward
publicHealth Canada · Canada · Updated Jun 3, 2026

Dexcom G7 Sensor Lot Recall – Unauthorized Distribution of Non-Conforming Lots in Canada

Urgency: High

Identify and quarantine products from lots 1725204004 and 1725069002; contact patients who received sensors from these lots; report adverse events if any.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medical Device Recall
Read impact briefarrow_forward
publicTGA · Australia · Updated Jun 3, 2026

Nature's Own Glucosamine Sulfate with Chondroitin and Nature's Own Magnesium Glycinate 1150mg Recall by Sanofi Consumer Healthcare

Urgency: High

Return recalled products to place of purchase for refund or contact Customer Care for return arrangements.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Recall
Read impact briefarrow_forward

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