Timely medical device recalls can prevent serious patient injury and even death; however, critics say that the FDA’s uncoordinated, paper-based system can delay critical recall communications for months, resulting in the continued use of potentially dangerous products.
Elite Medical Experts shares its take on the voluntary recall of specific Philips Respironics ventilators, BiPAP, and CPAP devices.
Hillrom’s recalled Liko Multirall 200 overhead patient lift has been linked to two deaths and there are more than 20 reports of serious injuries, reports MedTech Dive.
Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk the delivery system could fracture while placing the stent inside the patient. The U.S. FDA has identified this as a Class 1 recall—the most serious type.
Read More
GE Healthcare has recalled its Carestation 620/650/650c A1 anesthesia systems because there is a potential for a loose cable connection inside the system, which may cause the mechanical ventilation to stop working.
Read More
Stryker is notifying a population of LifePak 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the “Shock” button on the keypad is pressed.
Read More
Soom has introduced SoomSafety, an iOS mobile app that allows users to scan a medical device and receive instructions for use, safety, and medical device recalls directly from the device manufacturer and the U.S. FDA.
Read More
The FDA has identified GE’s infant warmer recall as a Class I recall, the most serious type of recall.
Read More
The U.S. FDA has recalled certain Medtronic MiniMed insulin pumps due to potential cybersecurity risks and recommends that patients using these devices switch their insulin pump to models that are better equipped to protect against these potential risks.
Read More
Stryker announces that the company is launching a voluntary field action on specific units of their Lifepak 15 monitor/defibrillators. Specifically, the company is notifying certain Lifepak 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered.
Read More
Medtronic is notifying customers worldwide of a voluntary field corrective action—a software update—for its Puritan Bennett 980 (PB980) ventilator series. The software updates the external USB Drive performance and its impact on Graphical User Interface (GUI) functionality and the labeling displayed on the GUI during ventilator use, Medtronic said in a statement.
Read More
Results of a new study into what influences the decision to recall a defective product found that medical device firm managers may rely on their physician-customers to screen out detectable defects, in lieu of issuing a recall. The study also found that some managers appear to hesitate to recall a product until the root cause of the defect is clearly understood, because this can reduce recall costs to the firm.
Read More
In the latest Soapbox column, biomedical engineering educator and expert, William Hyman, takes a closer look at the logistical challenges and difficult decisions triggered by the FDA’s ‘Do Not Use’ recalls on medical devices. Don’t miss out.
Read More
Although medical device recalls can be a challenge for any hospital, new regulations and technologies are starting to make this work a little easier, says seasoned writer Chris Hayhurst in October’s cover story. So, is your facility ready for a product recall? Assess your readiness here.
Read More
As part of your overall biomedical equipment management strategy, you should maintain a product recall process that allows your organization to react quickly and decisively to a recall situation, enBio Corp.’s Mike Murray and Arthur Zenian say. Below, they share how to accomplish this.
Read More