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Medical device recall

MEDIC L DEVICE RECALL In the last 15 years, the most common causes of medical product recalls were due to: Device software malfunction Defective design Nonconforming components or materials The most commonly recalled medical devices are: heart valves, pacemakers, prosthetic knees, hip devices and ventilators. Important fact about Medical Device Safety: TAKE NOTE The FDA does not monitor healthcare professionals who use products for unapproved uses. January - August 2016 24 medical products recalled. 6 MONTHS 24 RECALLS Device Defects: 4 Levels Of Reporting Responsibility. Manufacturers are legally required to notify the FDA of device defects with MDRS (Medical Device Reports) to be published as a notice to the public. Importers are required to notify the FDA of a device defect in case of death or serious injury. In case of malfunction they need to report to the manufacturer. Device user facilities hospitals, nursing homes, outpatient facilities, reporf to the FDA and the manufacturer in case of death. They can voluntarily report a device malfunction using MedWatch form or MedWatcher mobile app. Consumers, caregivers, patients and healthcare professionals MedWatch form if they know of or experience a medical product problem. encouraged to submit are a SOURCES http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/ cdrh/cdrhtransparency/ucm388442.pdf http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm480134.htm http://www.fda.gov/MedicalDevices/Safetý/ReportaProblem/default.htm https://www.injurylawyer.com/practice-areas/product-liability/defective-medical-products/ THE ROTHENBERG LAW FIRM LLP A PROUD HISTORY OF SUCCESS R 800-624-8888 Injury awyer.com 1234

Medical device recall

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Content Summary for The Medical Device Recall Infographic In the last 15 years, the most common causes of medical product recalls were due to: Device software malfunction Defective design Nonconformin...

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