Postmarket Safety

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July 14, 2020
MHRA Warns of Issues with DePuy Synthes’ Spinal Fixation System
The company said surgeons should “discuss the potential clinical implications and risks with symptomatic patients who received the affected implants.”
July 7, 2020
Australia’s TGA Re-Tests COVID-19 Antibody Tests
Australia’s Therapeutic Goods Administration (TGA) said it is reviewing all approved serology-based COVID-19 point-of-care tests to verify their ability to detect SARS-COV-2 antibodies.
July 1, 2020
MHRA Warns of Defect in Philips’ Defibrillator Selector Switch
The device may fail to turn on or may deliver a shock at a different energy level than selected, the agency said.

June 8, 2020
Australia’s TGA Re-Tests COVID-19 Antibody Tests
June 8, 2020
Four Deaths Trigger Recall for Medtronic’s HeartWare System
May 18, 2020
Allergan Warned for Postapproval Studies for Breast Implants
May 11, 2020
Australia Conducts Postmarket Review of COVID-19 Face Masks
May 11, 2020
Australia Conducts Postmarket Review of COVID-19 Face Masks

March 27, 2020
Philips Warns of HeartStart Monitor/Defibrillator Failures
March 24, 2020
FDA Warns of Possible Failure of EpiPen Injectors
March 12, 2020
FDA Announces Class I Recall of Heart Failure Support System
March 4, 2020
U.K. Announces Recall of Adrenaline Pens
February 27, 2020
MHRA Warns That Olympus Duodenoscopes May Have Frayed Wires