Postmarket Safety

Medtronic Provides Pump-Restart Controller Update for HeartWare Ventricular Assist Device

October 18, 2022

The new controller is “recommended only as a rescue,” the company said. Read More

Prostate Cancer Patients Need Fewer Treatments with Accuray’s Robotic Radiotherapy

October 12, 2022

Prostate cancer patients treated with Accuray’s CyberKnife robotic radiotherapy needed fewer sessions compared to patients treated with conventional radiotherapy, researchers reported in the journal The Lancet Oncology. Read More

Cybersecurity Firm Warns of Vulnerabilities in Canon Medical Vitrea View Software

October 5, 2022

If exploited, an attacker could access patient information and obtain additional access to various services associated with Vitrea View, said Trustwave Spiderlabs. Read More

FDA Provides Update on Recall of LifeSPARC Systems

October 4, 2022

There have been 66 complaints and two injuries associated with the issue, the agency said. Read More

FDA Offers Update on Philips Respironics’ Recall of BiPAP Machines

September 26, 2022

The recall is not associated with a June 2021 recall of the company’s BiPAP machines because of an issue with a foam material, the agency noted. Read More

FDA Issues Cybersecurity Alert on Medtronic MiniMed 600 Series Insulin Pump System

September 23, 2022

The FDA is not aware of any adverse event reports related to the cybersecurity vulnerability. Read More

FDA Gives Update on Baxter Healthcare’s Recall of Clearlink Basic Solution Sets with Duovent

September 19, 2022

There have been 83 complaints but no reports of injuries or deaths associated with this issue, the FDA said. Read More

FDA Updates Medtronic Xomed’s Recall of Two Types of NIM Endotracheal Tubes to Class 1

September 15, 2022

If the tube obstructs, ventilation failure can occur, which can lead to oxygen deprivation, brain damage or death. Read More

RAPS REPORT: Recall Response — Planning, Communication and Caring Will Build Customer Loyalty, Says Expert

September 14, 2022

Planning for a drug or device recall, training for it and executing it with a heaping helping of humility are the key steps to managing a recall without sinking your business, according to Matt Walker, director of business development for the risk management company Sedgwick. Read More

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Medtronic Provides Pump-Restart Controller Update for HeartWare Ventricular Assist Device

Prostate Cancer Patients Need Fewer Treatments with Accuray’s Robotic Radiotherapy

Cybersecurity Firm Warns of Vulnerabilities in Canon Medical Vitrea View Software

FDA Provides Update on Recall of LifeSPARC Systems

FDA Offers Update on Philips Respironics’ Recall of BiPAP Machines

FDA Issues Cybersecurity Alert on Medtronic MiniMed 600 Series Insulin Pump System

FDA Gives Update on Baxter Healthcare’s Recall of Clearlink Basic Solution Sets with Duovent

FDA Updates Medtronic Xomed’s Recall of Two Types of NIM Endotracheal Tubes to Class 1

RAPS REPORT: Recall Response — Planning, Communication and Caring Will Build Customer Loyalty, Says Expert

Abbott Recalls Heart Valve Repair Device MitraClip Over Reported Malfunctions

Philips Respironics Recalls BiPAP, CPAP Masks for Magnet Safety Issues

FDA Provides Update on Integra’s Recall of CereLink ICP Monitors

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