FDA Blocks Entry of Certain Olympus Devices Over Quality Concerns
Certain import devices from Olympus’ Aizu facility in Japan will be refused entry due to outstanding quality system violations, the FDA says.
Tag: recall
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BD Issues Correction for Infusion Pump Software
BD is correcting software for its Alaris Systems Manager and CCE Infusion Adapter after identifying a risk that outdated infusion parameters could be uploaded, potentially leading to incorrect dosing.
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Philips Files Lawsuit Against PSN Labs Over Foam Recall Damage
Philips has filed a lawsuit against PSN Labs, claiming incorrect analysis of foam material used in recalled ventilation devices.
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FDA Blocks Entry of Certain Olympus Devices Over Quality Concerns
Certain import devices from Olympus’ Aizu facility in Japan will be refused entry due to outstanding quality system violations, the FDA says.
Medtronic Recalls Duet EDMS Catheter for Disconnection Issue
Medtronic Neurosurgery is recalling the Duet EDMS catheter tubing due to a potential for catheter disconnection.
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GAO to Investigate FDA’s Medical Device Oversight
The Government Accountability Office (GAO) is launching an investigation into the U.S. FDA’s potentially ineffective policies for recalling medical devices, prompted by concerns raised by Senators Durbin and Blumenthal regarding the slow response to recalls of Philips Respironics CPAPs, BiPAPs, and mechanical ventilators.
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Fresenius Kabi Recalls Ivenix Pump Over Critical Mechanical Issue
Fresenius Kabi has issued an urgent recall of its Ivenix Large Volume Pump (LVP) for mechanical issues with the fluid valve pins.
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Olympus Recalls Bronchoscopes for Burn Risk
Olympus is recalling certain bronchofiberscopes and bronchovideoscopes because they may lead to burns or catch fire.
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Philips Recalls Panorama 1.0T HFO MRI System for Explosion Risk
Philips is recalling the Panorama 1.0T HFO due to risk of explosion during a quench procedure caused by excessive pressure buildup.
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Senators Call for Review of ‘Ineffective’ FDA Recall Policies
Senators Durbin and Blumenthal have requested the Government Accountability Office (GAO) to review the FDA’s policies on medical device recalls, citing the Philips Respironics case and a significant increase in recalls.
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MasterControl Study Finds 115% Increase in Recalls Over 5 Years
Despite a 115% increase in FDA recalls since 2018, MasterControl found that medical devices only contributed 4% of the total number.
